Osteoporosis

SAN FRANCISCO – Assessing renal health using a modified Cockroft-Gault equation to measure creatinine clearance was more sensitive than using the Modification of Diet in Renal Disease equation to estimate glomerular filtration rate when estimating risk for osteoporosis and fracture, an award-winning study of 400 postmenopausal Puerto Rican women showed.

The study found a high prevalence of mild renal dysfunction (stage 2 chronic kidney disease) in 54%-59% of women, depending on the equation used. With the Cockroft-Gault equation adjusted for body surface area, a determination of mild renal dysfunction was associated with significantly decreased bone mineral density and with a doubling in risk for vertebral or nonvertebral fractures. When the Modification of Diet in Renal Disease (MDRD) equation was used, however, no significant associations were found between mild renal dysfunction and fracture risk, Dr. Loida A. González-Rodriguez reported.

Previous data have shown that severe renal dysfunction is associated with reduced bone mineral density and fractures, and that a creatinine clearance below 65 mL/min per 1.73 m² is associated with a higher risk for falls and hip fractures in elderly people. Less is known about the effects of mild renal dysfunction on bone mineral density.

"We are postulating that this Cockroft-Gault equation is better to estimate bone," because it includes factors such as weight and age, and is adjusted for body surface area, Dr. González-Rodriguez said in an interview at the annual meeting of the Endocrine Society. She received an award at the meeting for her retrospective secondary analysis of data from the Latin American Vertebral Osteoporosis Study, the first population-based study of vertebral fractures in Latin America.

Many clinicians use the MDRD equation to estimate renal function. Dr. González-Rodriguez of the University of Puerto Rico, San Juan, said she has switched to using the Cockroft-Gault equation, and is trying to get colleagues at her institution to do the same. The MDRD equation will miss some patients who are at risk for osteopenia, osteoporosis, and fracture, she said.

Seventeen percent of patients in the study had normal bone mineral density, 43% had osteopenia, and 41% had osteoporosis. (Percentages were rounded and so exceed 100%.)

When the Cockroft-Gault equation was used to categorize renal function, 9% of patients had stage 1 chronic kidney disease, 54% had stage 2, 35% had stage 3, and 2% had stage 4. When the MDRD equation was used, 2% of patients had stage 1 chronic kidney disease, 59% had stage 2, 38% had stage 3, and 1% had stage 4.

Among patients with stage 2 chronic kidney disease as assessed by the Cockroft-Gault equation, 19% had normal bone mineral density, 49% had osteopenia, and 32% had osteoporosis. Among patients with stage 2 disease assessed using the MDRD equation, 4% had normal bone mineral density, 35% had osteopenia, and 60% had osteoporosis.

Vertebral fractures occurred in 9% and nonvertebral fractures occurred in 18% of patients with stage 2 disease assessed with the Cockroft-Gault equation. When the MDRD equation was used, 9% of patients with stage 2 disease developed vertebral fractures and 24% developed nonvertebral fractures.

Among patients with stage 3 chronic kidney disease assessed using the Cockroft-Gault equation, 18% developed vertebral fractures and 31% developed nonvertebral fractures, compared with vertebral fractures in 16% and nonvertebral fractures in 22% of patients with stage 3 disease assessed using the MDRD equation.

"One of the most important risk factors for vertebral and nonvertebral fractures is osteoporosis," Dr. González-Rodriguez noted. "So, if we can identify earlier the patients that have mild renal dysfunction" using the Cockroft-Gault equation and manage the osteoporosis risk, some fractures may be prevented.

The findings are limited by the retrospective design of the study, a lack of blood pressure measurements to assess arterial hypertension, self-reported nonvertebral fractures, and a lack of measurements of intact parathyroid hormone, 25-hydroxyvitamin D, and microalbuminuria.

Dr. González-Rodriguez reported having no relevant financial disclosures. The National Center for Research Resources and the National Institute on Minority Health and Health Disparities funded the study.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Assessing renal health using a modified Cockroft-Gault equation to measure creatinine clearance was more sensitive than using the Modification of Diet in Renal Disease equation to estimate glomerular filtration rate when estimating risk for osteoporosis and fracture, an award-winning study of 400 postmenopausal Puerto Rican women showed.

The study found a high prevalence of mild renal dysfunction (stage 2 chronic kidney disease) in 54%-59% of women, depending on the equation used. With the Cockroft-Gault equation adjusted for body surface area, a determination of mild renal dysfunction was associated with significantly decreased bone mineral density and with a doubling in risk for vertebral or nonvertebral fractures. When the Modification of Diet in Renal Disease (MDRD) equation was used, however, no significant associations were found between mild renal dysfunction and fracture risk, Dr. Loida A. González-Rodriguez reported.

Previous data have shown that severe renal dysfunction is associated with reduced bone mineral density and fractures, and that a creatinine clearance below 65 mL/min per 1.73 m² is associated with a higher risk for falls and hip fractures in elderly people. Less is known about the effects of mild renal dysfunction on bone mineral density.

"We are postulating that this Cockroft-Gault equation is better to estimate bone," because it includes factors such as weight and age, and is adjusted for body surface area, Dr. González-Rodriguez said in an interview at the annual meeting of the Endocrine Society. She received an award at the meeting for her retrospective secondary analysis of data from the Latin American Vertebral Osteoporosis Study, the first population-based study of vertebral fractures in Latin America.

Many clinicians use the MDRD equation to estimate renal function. Dr. González-Rodriguez of the University of Puerto Rico, San Juan, said she has switched to using the Cockroft-Gault equation, and is trying to get colleagues at her institution to do the same. The MDRD equation will miss some patients who are at risk for osteopenia, osteoporosis, and fracture, she said.

Seventeen percent of patients in the study had normal bone mineral density, 43% had osteopenia, and 41% had osteoporosis. (Percentages were rounded and so exceed 100%.)

When the Cockroft-Gault equation was used to categorize renal function, 9% of patients had stage 1 chronic kidney disease, 54% had stage 2, 35% had stage 3, and 2% had stage 4. When the MDRD equation was used, 2% of patients had stage 1 chronic kidney disease, 59% had stage 2, 38% had stage 3, and 1% had stage 4.

Among patients with stage 2 chronic kidney disease as assessed by the Cockroft-Gault equation, 19% had normal bone mineral density, 49% had osteopenia, and 32% had osteoporosis. Among patients with stage 2 disease assessed using the MDRD equation, 4% had normal bone mineral density, 35% had osteopenia, and 60% had osteoporosis.

Vertebral fractures occurred in 9% and nonvertebral fractures occurred in 18% of patients with stage 2 disease assessed with the Cockroft-Gault equation. When the MDRD equation was used, 9% of patients with stage 2 disease developed vertebral fractures and 24% developed nonvertebral fractures.

Among patients with stage 3 chronic kidney disease assessed using the Cockroft-Gault equation, 18% developed vertebral fractures and 31% developed nonvertebral fractures, compared with vertebral fractures in 16% and nonvertebral fractures in 22% of patients with stage 3 disease assessed using the MDRD equation.

"One of the most important risk factors for vertebral and nonvertebral fractures is osteoporosis," Dr. González-Rodriguez noted. "So, if we can identify earlier the patients that have mild renal dysfunction" using the Cockroft-Gault equation and manage the osteoporosis risk, some fractures may be prevented.

The findings are limited by the retrospective design of the study, a lack of blood pressure measurements to assess arterial hypertension, self-reported nonvertebral fractures, and a lack of measurements of intact parathyroid hormone, 25-hydroxyvitamin D, and microalbuminuria.

Dr. González-Rodriguez reported having no relevant financial disclosures. The National Center for Research Resources and the National Institute on Minority Health and Health Disparities funded the study.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Assessing renal health using a modified Cockroft-Gault equation to measure creatinine clearance was more sensitive than using the Modification of Diet in Renal Disease equation to estimate glomerular filtration rate when estimating risk for osteoporosis and fracture, an award-winning study of 400 postmenopausal Puerto Rican women showed.

The study found a high prevalence of mild renal dysfunction (stage 2 chronic kidney disease) in 54%-59% of women, depending on the equation used. With the Cockroft-Gault equation adjusted for body surface area, a determination of mild renal dysfunction was associated with significantly decreased bone mineral density and with a doubling in risk for vertebral or nonvertebral fractures. When the Modification of Diet in Renal Disease (MDRD) equation was used, however, no significant associations were found between mild renal dysfunction and fracture risk, Dr. Loida A. González-Rodriguez reported.

Previous data have shown that severe renal dysfunction is associated with reduced bone mineral density and fractures, and that a creatinine clearance below 65 mL/min per 1.73 m² is associated with a higher risk for falls and hip fractures in elderly people. Less is known about the effects of mild renal dysfunction on bone mineral density.

"We are postulating that this Cockroft-Gault equation is better to estimate bone," because it includes factors such as weight and age, and is adjusted for body surface area, Dr. González-Rodriguez said in an interview at the annual meeting of the Endocrine Society. She received an award at the meeting for her retrospective secondary analysis of data from the Latin American Vertebral Osteoporosis Study, the first population-based study of vertebral fractures in Latin America.

Many clinicians use the MDRD equation to estimate renal function. Dr. González-Rodriguez of the University of Puerto Rico, San Juan, said she has switched to using the Cockroft-Gault equation, and is trying to get colleagues at her institution to do the same. The MDRD equation will miss some patients who are at risk for osteopenia, osteoporosis, and fracture, she said.

Seventeen percent of patients in the study had normal bone mineral density, 43% had osteopenia, and 41% had osteoporosis. (Percentages were rounded and so exceed 100%.)

When the Cockroft-Gault equation was used to categorize renal function, 9% of patients had stage 1 chronic kidney disease, 54% had stage 2, 35% had stage 3, and 2% had stage 4. When the MDRD equation was used, 2% of patients had stage 1 chronic kidney disease, 59% had stage 2, 38% had stage 3, and 1% had stage 4.

Among patients with stage 2 chronic kidney disease as assessed by the Cockroft-Gault equation, 19% had normal bone mineral density, 49% had osteopenia, and 32% had osteoporosis. Among patients with stage 2 disease assessed using the MDRD equation, 4% had normal bone mineral density, 35% had osteopenia, and 60% had osteoporosis.

Vertebral fractures occurred in 9% and nonvertebral fractures occurred in 18% of patients with stage 2 disease assessed with the Cockroft-Gault equation. When the MDRD equation was used, 9% of patients with stage 2 disease developed vertebral fractures and 24% developed nonvertebral fractures.

Among patients with stage 3 chronic kidney disease assessed using the Cockroft-Gault equation, 18% developed vertebral fractures and 31% developed nonvertebral fractures, compared with vertebral fractures in 16% and nonvertebral fractures in 22% of patients with stage 3 disease assessed using the MDRD equation.

"One of the most important risk factors for vertebral and nonvertebral fractures is osteoporosis," Dr. González-Rodriguez noted. "So, if we can identify earlier the patients that have mild renal dysfunction" using the Cockroft-Gault equation and manage the osteoporosis risk, some fractures may be prevented.

The findings are limited by the retrospective design of the study, a lack of blood pressure measurements to assess arterial hypertension, self-reported nonvertebral fractures, and a lack of measurements of intact parathyroid hormone, 25-hydroxyvitamin D, and microalbuminuria.

Dr. González-Rodriguez reported having no relevant financial disclosures. The National Center for Research Resources and the National Institute on Minority Health and Health Disparities funded the study.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Hormonal therapies for transgender patients that block puberty and/or deliver opposite-sex hormones did not adversely affect bone development in adolescents and caused no serious side effects in teens or adults, two studies found.

The separate European studies, presented at the Endocrine Society Annual Meeting, looked at 127 adolescents aged 12-18 years in one study and 104 adults in the other study who were followed for 1 year after starting hormonal therapy.

The adolescents started gonadotropin-releasing hormone analogues (GnRHa) at ages 12-16 years to block production of sex hormones that initiate puberty, and at age 16 years they began receiving cross-sex hormones (either estrogen or testosterone) to induce sexual characteristics of the opposite sex to which they were transitioning. Adolescence is a key period for developing bone mass, so investigators followed patients’ bone density and other measures to see if there were any long-term adverse effects.

All patients had normal whole-body and hip-bone mineral density before hormonal therapy started. Bone density gradually increased in younger patients during GnRHa treatment, but less than would be expected without GnRHa. In patients who started GnRHa at relatively older ages, bone density decreased slightly, but both groups caught up to normal or near-normal bone density once they got cross-sex hormones and developed physiologic puberty. Patients who started the medical intervention with GnRHa at a young age and, thus, an early pubertal stage, showed the best bone density, reported Dr. Henriette Delemarre-van de Waal and her associates.

"The medical intervention in young transsexuals appears to be safe and effective," said Dr. Delemarre-van de Waal, professor of pediatric endocrinology at Leiden (Netherlands) University.

Patients reported satisfaction and no regrets about GnRHa therapy, but many commented that they would have liked to take cross-sex hormones earlier than age 16, she added at a press briefing on her study. Current Dutch law and Endocrine Society guidelines for treating transgender persons, which Dr. Delemarre-van de Waal helped develop, recommend waiting until age 16 to start cross-sex hormones. Efforts are underway to talk with the Dutch government about lowering the starting age of cross-sex hormonal therapy for selected patients, she said in an interview. Puberty in European girls starts at 10-11 years of age, so starting GnRHa before age 12 and cross-sex hormones before age 16 might optimize bone mass development, "but I think we need a little more data," she said.

Neither lipid levels nor insulin sensitivity per Tanner stage were adversely affected by puberty suppression or cross-sex hormones. GnRHa therapy delayed growth not only in bone age but in height, which was a concern especially for female-to-male transitioning patients who hoped to achieve the average taller height of males. Individualizing the addition of the anabolic steroid oxandrolone to cross-sex therapy helped achieve appropriate height in these patients, and estrogen therapy in male-to-female transgender patients suppressed growth velocity in height as desired by those patients.

A separate ongoing, prospective study analyzed data from four established gender-treatment teams in Belgium, the Netherlands, Norway, and Italy on 104 transgender adults in order to increase the limited knowledge about side effects from hormonal therapy. Females transitioning to males received standardized treatment with intramuscular testosterone undecanoate for 12 weeks. Males transitioning to females who were 45 years of age or younger were treated with standardized regimens of cyproterone acetate and estradiol valerate. Older male-to-female transsexuals received cyproterone acetate and a transdermal estradiol patch.

A year after starting therapy, no patients had developed adverse events serious enough to stop therapy, reported Dr. Katrien Wierckx of Ghent (Belgium) University and her associates. There were no deaths, cardiovascular events, osteoporotic fractures, venous thrombosis, pulmonary embolism, or prolactinomas.

Female-to-male transmen reported a significant increase in sex drive, voice instability, and androgenetic alopecia. Investigators observed significant increases in acne scores and total body lean mass, lower total body fat mass, and development of a less favorable lipid profile with lower high-density lipoprotein (HDL) levels and higher triglyceride levels, Dr. Wierckx said.

Male-to-female transwomen reported a significant decrease in sex drive and significant increases in breast tenderness, emotionality, and hot flashes. The hot flashes surprised investigators because this side effect had not been reported in previous studies. Measurements showed significant gains in fat mass, losses in muscle mass, and decreased insulin sensitivity. They developed a more favorable lipid profile with significantly reduced levels of total and low-density lipoprotein (LDL) cholesterol and triglycerides.

The findings suggest that current treatment regimens for transsexual women and men carry a low risk for short-term adverse events, Dr. Wierckx said. "These results are somewhat in contrast with most previously published studies, which observed a high incidence of venous thrombosis or pulmonary embolism during the first year of treatment," she said. This may suggest that treatment regimens avoiding the use of high-dose estradiol and high-dose cyproterone acetate have less detrimental effects on the coagulation system, she suggested.

Plenty of questions remain about the long-term effects of hormonal therapy for sex transitions. "There are a lot of concerns. It’s still a controversial subject," said Dr. Delemarre-van de Waal. Effects on brain development are a key concern, but preliminary data from serial MRIs and functional MRIs of transgender patients have not produced any alarming findings, she said.

Both speakers reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Hormonal therapies for transgender patients that block puberty and/or deliver opposite-sex hormones did not adversely affect bone development in adolescents and caused no serious side effects in teens or adults, two studies found.

The separate European studies, presented at the Endocrine Society Annual Meeting, looked at 127 adolescents aged 12-18 years in one study and 104 adults in the other study who were followed for 1 year after starting hormonal therapy.

The adolescents started gonadotropin-releasing hormone analogues (GnRHa) at ages 12-16 years to block production of sex hormones that initiate puberty, and at age 16 years they began receiving cross-sex hormones (either estrogen or testosterone) to induce sexual characteristics of the opposite sex to which they were transitioning. Adolescence is a key period for developing bone mass, so investigators followed patients’ bone density and other measures to see if there were any long-term adverse effects.

All patients had normal whole-body and hip-bone mineral density before hormonal therapy started. Bone density gradually increased in younger patients during GnRHa treatment, but less than would be expected without GnRHa. In patients who started GnRHa at relatively older ages, bone density decreased slightly, but both groups caught up to normal or near-normal bone density once they got cross-sex hormones and developed physiologic puberty. Patients who started the medical intervention with GnRHa at a young age and, thus, an early pubertal stage, showed the best bone density, reported Dr. Henriette Delemarre-van de Waal and her associates.

"The medical intervention in young transsexuals appears to be safe and effective," said Dr. Delemarre-van de Waal, professor of pediatric endocrinology at Leiden (Netherlands) University.

Patients reported satisfaction and no regrets about GnRHa therapy, but many commented that they would have liked to take cross-sex hormones earlier than age 16, she added at a press briefing on her study. Current Dutch law and Endocrine Society guidelines for treating transgender persons, which Dr. Delemarre-van de Waal helped develop, recommend waiting until age 16 to start cross-sex hormones. Efforts are underway to talk with the Dutch government about lowering the starting age of cross-sex hormonal therapy for selected patients, she said in an interview. Puberty in European girls starts at 10-11 years of age, so starting GnRHa before age 12 and cross-sex hormones before age 16 might optimize bone mass development, "but I think we need a little more data," she said.

Neither lipid levels nor insulin sensitivity per Tanner stage were adversely affected by puberty suppression or cross-sex hormones. GnRHa therapy delayed growth not only in bone age but in height, which was a concern especially for female-to-male transitioning patients who hoped to achieve the average taller height of males. Individualizing the addition of the anabolic steroid oxandrolone to cross-sex therapy helped achieve appropriate height in these patients, and estrogen therapy in male-to-female transgender patients suppressed growth velocity in height as desired by those patients.

A separate ongoing, prospective study analyzed data from four established gender-treatment teams in Belgium, the Netherlands, Norway, and Italy on 104 transgender adults in order to increase the limited knowledge about side effects from hormonal therapy. Females transitioning to males received standardized treatment with intramuscular testosterone undecanoate for 12 weeks. Males transitioning to females who were 45 years of age or younger were treated with standardized regimens of cyproterone acetate and estradiol valerate. Older male-to-female transsexuals received cyproterone acetate and a transdermal estradiol patch.

A year after starting therapy, no patients had developed adverse events serious enough to stop therapy, reported Dr. Katrien Wierckx of Ghent (Belgium) University and her associates. There were no deaths, cardiovascular events, osteoporotic fractures, venous thrombosis, pulmonary embolism, or prolactinomas.

Female-to-male transmen reported a significant increase in sex drive, voice instability, and androgenetic alopecia. Investigators observed significant increases in acne scores and total body lean mass, lower total body fat mass, and development of a less favorable lipid profile with lower high-density lipoprotein (HDL) levels and higher triglyceride levels, Dr. Wierckx said.

Male-to-female transwomen reported a significant decrease in sex drive and significant increases in breast tenderness, emotionality, and hot flashes. The hot flashes surprised investigators because this side effect had not been reported in previous studies. Measurements showed significant gains in fat mass, losses in muscle mass, and decreased insulin sensitivity. They developed a more favorable lipid profile with significantly reduced levels of total and low-density lipoprotein (LDL) cholesterol and triglycerides.

The findings suggest that current treatment regimens for transsexual women and men carry a low risk for short-term adverse events, Dr. Wierckx said. "These results are somewhat in contrast with most previously published studies, which observed a high incidence of venous thrombosis or pulmonary embolism during the first year of treatment," she said. This may suggest that treatment regimens avoiding the use of high-dose estradiol and high-dose cyproterone acetate have less detrimental effects on the coagulation system, she suggested.

Plenty of questions remain about the long-term effects of hormonal therapy for sex transitions. "There are a lot of concerns. It’s still a controversial subject," said Dr. Delemarre-van de Waal. Effects on brain development are a key concern, but preliminary data from serial MRIs and functional MRIs of transgender patients have not produced any alarming findings, she said.

Both speakers reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Hormonal therapies for transgender patients that block puberty and/or deliver opposite-sex hormones did not adversely affect bone development in adolescents and caused no serious side effects in teens or adults, two studies found.

The separate European studies, presented at the Endocrine Society Annual Meeting, looked at 127 adolescents aged 12-18 years in one study and 104 adults in the other study who were followed for 1 year after starting hormonal therapy.

The adolescents started gonadotropin-releasing hormone analogues (GnRHa) at ages 12-16 years to block production of sex hormones that initiate puberty, and at age 16 years they began receiving cross-sex hormones (either estrogen or testosterone) to induce sexual characteristics of the opposite sex to which they were transitioning. Adolescence is a key period for developing bone mass, so investigators followed patients’ bone density and other measures to see if there were any long-term adverse effects.

All patients had normal whole-body and hip-bone mineral density before hormonal therapy started. Bone density gradually increased in younger patients during GnRHa treatment, but less than would be expected without GnRHa. In patients who started GnRHa at relatively older ages, bone density decreased slightly, but both groups caught up to normal or near-normal bone density once they got cross-sex hormones and developed physiologic puberty. Patients who started the medical intervention with GnRHa at a young age and, thus, an early pubertal stage, showed the best bone density, reported Dr. Henriette Delemarre-van de Waal and her associates.

"The medical intervention in young transsexuals appears to be safe and effective," said Dr. Delemarre-van de Waal, professor of pediatric endocrinology at Leiden (Netherlands) University.

Patients reported satisfaction and no regrets about GnRHa therapy, but many commented that they would have liked to take cross-sex hormones earlier than age 16, she added at a press briefing on her study. Current Dutch law and Endocrine Society guidelines for treating transgender persons, which Dr. Delemarre-van de Waal helped develop, recommend waiting until age 16 to start cross-sex hormones. Efforts are underway to talk with the Dutch government about lowering the starting age of cross-sex hormonal therapy for selected patients, she said in an interview. Puberty in European girls starts at 10-11 years of age, so starting GnRHa before age 12 and cross-sex hormones before age 16 might optimize bone mass development, "but I think we need a little more data," she said.

Neither lipid levels nor insulin sensitivity per Tanner stage were adversely affected by puberty suppression or cross-sex hormones. GnRHa therapy delayed growth not only in bone age but in height, which was a concern especially for female-to-male transitioning patients who hoped to achieve the average taller height of males. Individualizing the addition of the anabolic steroid oxandrolone to cross-sex therapy helped achieve appropriate height in these patients, and estrogen therapy in male-to-female transgender patients suppressed growth velocity in height as desired by those patients.

A separate ongoing, prospective study analyzed data from four established gender-treatment teams in Belgium, the Netherlands, Norway, and Italy on 104 transgender adults in order to increase the limited knowledge about side effects from hormonal therapy. Females transitioning to males received standardized treatment with intramuscular testosterone undecanoate for 12 weeks. Males transitioning to females who were 45 years of age or younger were treated with standardized regimens of cyproterone acetate and estradiol valerate. Older male-to-female transsexuals received cyproterone acetate and a transdermal estradiol patch.

A year after starting therapy, no patients had developed adverse events serious enough to stop therapy, reported Dr. Katrien Wierckx of Ghent (Belgium) University and her associates. There were no deaths, cardiovascular events, osteoporotic fractures, venous thrombosis, pulmonary embolism, or prolactinomas.

Female-to-male transmen reported a significant increase in sex drive, voice instability, and androgenetic alopecia. Investigators observed significant increases in acne scores and total body lean mass, lower total body fat mass, and development of a less favorable lipid profile with lower high-density lipoprotein (HDL) levels and higher triglyceride levels, Dr. Wierckx said.

Male-to-female transwomen reported a significant decrease in sex drive and significant increases in breast tenderness, emotionality, and hot flashes. The hot flashes surprised investigators because this side effect had not been reported in previous studies. Measurements showed significant gains in fat mass, losses in muscle mass, and decreased insulin sensitivity. They developed a more favorable lipid profile with significantly reduced levels of total and low-density lipoprotein (LDL) cholesterol and triglycerides.

The findings suggest that current treatment regimens for transsexual women and men carry a low risk for short-term adverse events, Dr. Wierckx said. "These results are somewhat in contrast with most previously published studies, which observed a high incidence of venous thrombosis or pulmonary embolism during the first year of treatment," she said. This may suggest that treatment regimens avoiding the use of high-dose estradiol and high-dose cyproterone acetate have less detrimental effects on the coagulation system, she suggested.

Plenty of questions remain about the long-term effects of hormonal therapy for sex transitions. "There are a lot of concerns. It’s still a controversial subject," said Dr. Delemarre-van de Waal. Effects on brain development are a key concern, but preliminary data from serial MRIs and functional MRIs of transgender patients have not produced any alarming findings, she said.

Both speakers reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

CHICAGO – High-dose vitamin D₂ supplementation shows promise for the treatment of chronic pain among women with type 2 diabetes and comorbid depression, according to a single-arm pilot study known as the Sunshine Study.

The vitamin D₂ supplementation at 50,000 IU/week for 6 months also was associated with significant improvement in major depressive disorder in this uncontrolled study, Sue M. Penckofer, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

This was a small, hypothesis-generating study of a relatively low-cost and safe potential therapy for a common clinical condition. The encouraging results have led to a $1.5 million grant from the National Institutes of Health for a considerably larger 4-year randomized controlled trial due to begin later this year, said Dr. Penckofer, professor of nursing at Loyola University in Maywood, Ill.

The pilot study included 46 women with type 2 diabetes, major depressive disorder, and vitamin D insufficiency as evidenced by their mean baseline serum level of 18 ng/mL. They averaged 54.6 years of age, with a 7.8-year history of diabetes and a mean hemoglobin A_1c of 6.8%. Twenty-eight of the women had neuropathic pain involving their legs and 34 had sensory pain, with numbness or tingling in their feet and/or legs.

After 6 months of weekly vitamin D supplementation, the subjects’ mean vitamin D blood level had climbed to 38 ng/mL. Their median score on the Center for Epidemiologic Studies Depression Scale improved from 26.8 at baseline to 12.2 and their depression rating on the Patient Health Questionnaire (PHQ-9) improved from 11.5 to 5.2, although their antidepressant medication regimens were not required to be held constant.

Scores on the neuropathic pain subscale of the Diabetes Symptom Checklist improved from a baseline of 3.2 to 1.8 at 3 months and 2.1 at 6 months. Scores on the sensory pain subscale improved from 7.3 at baseline to 5.0 at 3 months and 5.9 at 6 months. These favorable trends didn’t attain statistical significance in such a small study population, but patients in the top half of the group in terms of neuropathic or sensory pain did show statistically significant improvement over time. Those in the high baseline neuropathic pain group went from an average score of 5.2 at enrollment to 2.5 at 3 months and 2.8 at 6 months. Similarly, the high sensory pain subgroup improved from a baseline score of 10.6 to 6.8 at 3 months and 6.9 at 6 months, according to Dr. Penckofer.

The Sunshine Study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Penckofer reported having no conflicts of interest.

[email protected]

CHICAGO – High-dose vitamin D₂ supplementation shows promise for the treatment of chronic pain among women with type 2 diabetes and comorbid depression, according to a single-arm pilot study known as the Sunshine Study.

The vitamin D₂ supplementation at 50,000 IU/week for 6 months also was associated with significant improvement in major depressive disorder in this uncontrolled study, Sue M. Penckofer, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

This was a small, hypothesis-generating study of a relatively low-cost and safe potential therapy for a common clinical condition. The encouraging results have led to a $1.5 million grant from the National Institutes of Health for a considerably larger 4-year randomized controlled trial due to begin later this year, said Dr. Penckofer, professor of nursing at Loyola University in Maywood, Ill.

The pilot study included 46 women with type 2 diabetes, major depressive disorder, and vitamin D insufficiency as evidenced by their mean baseline serum level of 18 ng/mL. They averaged 54.6 years of age, with a 7.8-year history of diabetes and a mean hemoglobin A_1c of 6.8%. Twenty-eight of the women had neuropathic pain involving their legs and 34 had sensory pain, with numbness or tingling in their feet and/or legs.

After 6 months of weekly vitamin D supplementation, the subjects’ mean vitamin D blood level had climbed to 38 ng/mL. Their median score on the Center for Epidemiologic Studies Depression Scale improved from 26.8 at baseline to 12.2 and their depression rating on the Patient Health Questionnaire (PHQ-9) improved from 11.5 to 5.2, although their antidepressant medication regimens were not required to be held constant.

Scores on the neuropathic pain subscale of the Diabetes Symptom Checklist improved from a baseline of 3.2 to 1.8 at 3 months and 2.1 at 6 months. Scores on the sensory pain subscale improved from 7.3 at baseline to 5.0 at 3 months and 5.9 at 6 months. These favorable trends didn’t attain statistical significance in such a small study population, but patients in the top half of the group in terms of neuropathic or sensory pain did show statistically significant improvement over time. Those in the high baseline neuropathic pain group went from an average score of 5.2 at enrollment to 2.5 at 3 months and 2.8 at 6 months. Similarly, the high sensory pain subgroup improved from a baseline score of 10.6 to 6.8 at 3 months and 6.9 at 6 months, according to Dr. Penckofer.

The Sunshine Study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Penckofer reported having no conflicts of interest.

[email protected]

CHICAGO – High-dose vitamin D₂ supplementation shows promise for the treatment of chronic pain among women with type 2 diabetes and comorbid depression, according to a single-arm pilot study known as the Sunshine Study.

The vitamin D₂ supplementation at 50,000 IU/week for 6 months also was associated with significant improvement in major depressive disorder in this uncontrolled study, Sue M. Penckofer, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

This was a small, hypothesis-generating study of a relatively low-cost and safe potential therapy for a common clinical condition. The encouraging results have led to a $1.5 million grant from the National Institutes of Health for a considerably larger 4-year randomized controlled trial due to begin later this year, said Dr. Penckofer, professor of nursing at Loyola University in Maywood, Ill.

The pilot study included 46 women with type 2 diabetes, major depressive disorder, and vitamin D insufficiency as evidenced by their mean baseline serum level of 18 ng/mL. They averaged 54.6 years of age, with a 7.8-year history of diabetes and a mean hemoglobin A_1c of 6.8%. Twenty-eight of the women had neuropathic pain involving their legs and 34 had sensory pain, with numbness or tingling in their feet and/or legs.

After 6 months of weekly vitamin D supplementation, the subjects’ mean vitamin D blood level had climbed to 38 ng/mL. Their median score on the Center for Epidemiologic Studies Depression Scale improved from 26.8 at baseline to 12.2 and their depression rating on the Patient Health Questionnaire (PHQ-9) improved from 11.5 to 5.2, although their antidepressant medication regimens were not required to be held constant.

Scores on the neuropathic pain subscale of the Diabetes Symptom Checklist improved from a baseline of 3.2 to 1.8 at 3 months and 2.1 at 6 months. Scores on the sensory pain subscale improved from 7.3 at baseline to 5.0 at 3 months and 5.9 at 6 months. These favorable trends didn’t attain statistical significance in such a small study population, but patients in the top half of the group in terms of neuropathic or sensory pain did show statistically significant improvement over time. Those in the high baseline neuropathic pain group went from an average score of 5.2 at enrollment to 2.5 at 3 months and 2.8 at 6 months. Similarly, the high sensory pain subgroup improved from a baseline score of 10.6 to 6.8 at 3 months and 6.9 at 6 months, according to Dr. Penckofer.

The Sunshine Study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Penckofer reported having no conflicts of interest.

[email protected]

SAN FRANCISCO – Only one-quarter of patients who were informed by mail to take vitamin D because of insufficient levels found in a blood test met their target of at least 30 ng/mL 6 months later, according to a chart review.

This less-than-ideal compliance among 338 osteopenic patients in a University of Toronto osteoporosis program may be partly attributable to the fact that the importance of the treatment wasn’t adequately addressed while the patients were in the clinic.

After blood tests there, 265 patients (78%) were mailed a form letter telling them that they had insufficient vitamin D levels, defined as 20-29 ng/mL, and to take 4,000 IU/day for 3 months and then 2,000 IU/day thereafter.

Meanwhile, 73 (22%) received a letter telling them they were deficient, with levels of less than 20 ng/mL, and to take one 50,000 IU pill per week and 2,000 IU/day for 3 months, then switch to 2,000 IU/day.

"We were recommending fairly high doses of vitamin D, and that may have been intimidating," especially for a largely asymptomatic condition. "There was no chance really for them to discuss face-to-face with a clinician what their vitamin D status meant, and what treatment entailed," lead investigator Dr. Vithika Sivabalasundaram, an internal medicine resident at the university, said at the Endocrine Society’s annual meeting.

Perhaps not surprisingly, only half (169) of the patients followed through with repeat blood tests after 6 months, as instructed. Of those, just 56% (95) met the target of at least 30 ng/mL. The others (74) were largely unchanged or actually lost ground.

The lesson is probably that "we need to inform our patients of the benefits of vitamin D on bone health, and that there’s fairly low toxicity associated with taking vitamin D," Dr. Sivabalasundaram said.

To that end, when patients get their blood drawn in the clinic, they’re now "informed that they might be placed on this vitamin D protocol, so when they receive the letter, they are not surprised by it and they understand what it means. That wasn’t done before. We are [also] having a nurse phone [patients] to discuss their vitamin D status and answer their questions. We are developing an information pamphlet" as well, and plan to translate the letter into other languages, she said, adding that "right now, we are just sending [it] out in English," which may be a problem for the clinic’s multicultural population.

The only predictor of hitting the 30 ng/mL mark in the study was how soon after 6 months patients got their blood checked, which was probably a surrogate for how seriously they took the protocol, Dr. Sivabalasundaram said.

Baseline vitamin D status and use of glucocorticoids didn’t predict success, nor did past osteoporotic fractures. "We thought that would motivate patients, but we didn’t see that," she said.

Patients with malabsorption syndrome were less likely to hit the mark, as were obese patients, "which makes sense because vitamin D is sequestered into fat cells," she said.

Patients were about 60 years old on average, mostly women, and mostly white.

Dr. Sivabalasundaram said that she had no conflicts to disclose. One of her coinvestigators has been a speaker and advisory group member for several pharmaceutical companies.

[email protected]

SAN FRANCISCO – Only one-quarter of patients who were informed by mail to take vitamin D because of insufficient levels found in a blood test met their target of at least 30 ng/mL 6 months later, according to a chart review.

This less-than-ideal compliance among 338 osteopenic patients in a University of Toronto osteoporosis program may be partly attributable to the fact that the importance of the treatment wasn’t adequately addressed while the patients were in the clinic.

After blood tests there, 265 patients (78%) were mailed a form letter telling them that they had insufficient vitamin D levels, defined as 20-29 ng/mL, and to take 4,000 IU/day for 3 months and then 2,000 IU/day thereafter.

Meanwhile, 73 (22%) received a letter telling them they were deficient, with levels of less than 20 ng/mL, and to take one 50,000 IU pill per week and 2,000 IU/day for 3 months, then switch to 2,000 IU/day.

"We were recommending fairly high doses of vitamin D, and that may have been intimidating," especially for a largely asymptomatic condition. "There was no chance really for them to discuss face-to-face with a clinician what their vitamin D status meant, and what treatment entailed," lead investigator Dr. Vithika Sivabalasundaram, an internal medicine resident at the university, said at the Endocrine Society’s annual meeting.

Perhaps not surprisingly, only half (169) of the patients followed through with repeat blood tests after 6 months, as instructed. Of those, just 56% (95) met the target of at least 30 ng/mL. The others (74) were largely unchanged or actually lost ground.

The lesson is probably that "we need to inform our patients of the benefits of vitamin D on bone health, and that there’s fairly low toxicity associated with taking vitamin D," Dr. Sivabalasundaram said.

To that end, when patients get their blood drawn in the clinic, they’re now "informed that they might be placed on this vitamin D protocol, so when they receive the letter, they are not surprised by it and they understand what it means. That wasn’t done before. We are [also] having a nurse phone [patients] to discuss their vitamin D status and answer their questions. We are developing an information pamphlet" as well, and plan to translate the letter into other languages, she said, adding that "right now, we are just sending [it] out in English," which may be a problem for the clinic’s multicultural population.

The only predictor of hitting the 30 ng/mL mark in the study was how soon after 6 months patients got their blood checked, which was probably a surrogate for how seriously they took the protocol, Dr. Sivabalasundaram said.

Baseline vitamin D status and use of glucocorticoids didn’t predict success, nor did past osteoporotic fractures. "We thought that would motivate patients, but we didn’t see that," she said.

Patients with malabsorption syndrome were less likely to hit the mark, as were obese patients, "which makes sense because vitamin D is sequestered into fat cells," she said.

Patients were about 60 years old on average, mostly women, and mostly white.

Dr. Sivabalasundaram said that she had no conflicts to disclose. One of her coinvestigators has been a speaker and advisory group member for several pharmaceutical companies.

[email protected]

SAN FRANCISCO – Only one-quarter of patients who were informed by mail to take vitamin D because of insufficient levels found in a blood test met their target of at least 30 ng/mL 6 months later, according to a chart review.

This less-than-ideal compliance among 338 osteopenic patients in a University of Toronto osteoporosis program may be partly attributable to the fact that the importance of the treatment wasn’t adequately addressed while the patients were in the clinic.

After blood tests there, 265 patients (78%) were mailed a form letter telling them that they had insufficient vitamin D levels, defined as 20-29 ng/mL, and to take 4,000 IU/day for 3 months and then 2,000 IU/day thereafter.

Meanwhile, 73 (22%) received a letter telling them they were deficient, with levels of less than 20 ng/mL, and to take one 50,000 IU pill per week and 2,000 IU/day for 3 months, then switch to 2,000 IU/day.

"We were recommending fairly high doses of vitamin D, and that may have been intimidating," especially for a largely asymptomatic condition. "There was no chance really for them to discuss face-to-face with a clinician what their vitamin D status meant, and what treatment entailed," lead investigator Dr. Vithika Sivabalasundaram, an internal medicine resident at the university, said at the Endocrine Society’s annual meeting.

Perhaps not surprisingly, only half (169) of the patients followed through with repeat blood tests after 6 months, as instructed. Of those, just 56% (95) met the target of at least 30 ng/mL. The others (74) were largely unchanged or actually lost ground.

The lesson is probably that "we need to inform our patients of the benefits of vitamin D on bone health, and that there’s fairly low toxicity associated with taking vitamin D," Dr. Sivabalasundaram said.

To that end, when patients get their blood drawn in the clinic, they’re now "informed that they might be placed on this vitamin D protocol, so when they receive the letter, they are not surprised by it and they understand what it means. That wasn’t done before. We are [also] having a nurse phone [patients] to discuss their vitamin D status and answer their questions. We are developing an information pamphlet" as well, and plan to translate the letter into other languages, she said, adding that "right now, we are just sending [it] out in English," which may be a problem for the clinic’s multicultural population.

The only predictor of hitting the 30 ng/mL mark in the study was how soon after 6 months patients got their blood checked, which was probably a surrogate for how seriously they took the protocol, Dr. Sivabalasundaram said.

Baseline vitamin D status and use of glucocorticoids didn’t predict success, nor did past osteoporotic fractures. "We thought that would motivate patients, but we didn’t see that," she said.

Patients with malabsorption syndrome were less likely to hit the mark, as were obese patients, "which makes sense because vitamin D is sequestered into fat cells," she said.

Patients were about 60 years old on average, mostly women, and mostly white.

Dr. Sivabalasundaram said that she had no conflicts to disclose. One of her coinvestigators has been a speaker and advisory group member for several pharmaceutical companies.

[email protected]

SYDNEY, AUSTRALIA – Friedreich’s ataxia patients may be at greater risk of osteopenia and osteoporotic fractures, according to a study showing significant decreases in bone mineral density at key sites such as the femoral neck.

Data presented in a poster at the international congress of Parkinson’s Disease and Movement Disorders also showed a correlation between Friedreich’s ataxia disease severity measures and bone mineral density measures.

Dr. Wolfgang Nachbauer of the department of neurology at Innsbruck (Austria) Medical University and his colleagues measured bone mineral density of the femur, lumbar vertebral column, radius, and ulna, using dual-energy x-ray absorptiometry in 20 patients with Friedreich’s ataxia. Mean age of the patients was 39.4 years.

They found 45% of patients (9 of 20) had osteoporosis at the femur, and 20% (4 of 20) had osteopenia at the same site, while bone mineral density measurements of the lumbar vertebral column showed osteopenia in 30% (6 of 20) and osteoporosis in 10% (2 of 20). Seven patients (35%) had osteopenia in the forearm.

Dr. Nachbauer said this was the first study exploring the incidence of osteopenia and osteoporosis in patients with this disorder.

"We observed clinically some pathological fractures within our Friedreich’s ataxia patients and together with the known action of the iron metabolism it made us think there could be an increased prevalence of osteoporosis and osteopenia with Friedreich’s ataxia," Dr. Nachbauer said in an interview.

Friedreich’s ataxia is a neurodegenerative disorder caused by a mutation in the frataxin gene, which codes for a protein involved in mitochondrial oxidative metabolism and iron homeostasis. Nonneurologic manifestations of Friedreich’s ataxia include scoliosis and foot deformities.

The study found that the most significant decreases in bone mineral density were at the femoral neck site, which is also a common site for hip fracture.

The researchers also examined the correlation between degree of bone mineral density loss and clinical indicators of disease severity in Friedreich’s ataxia. They found a significant, negative association between bone mineral density measurements at the femoral neck and scores on the Scale for the Assessment and Rating of Ataxia (SARA) and the length of GAA allele repeats in the frataxin gene – the defining feature of Friedreich’s ataxia.

"We also used the FRAX score, which is the score for the risk of pathological fractures within the next 10 years and also this score was increased in Friedreich’s ataxia patients," Dr. Nachbauer said.

While there were no significant interactions between potential confounders such as age and body mass index, the study found that wheelchair-bound patients had significantly lower bone density, compared with mobile patients.

The findings offer an opportunity for early intervention to address what may be a significant comorbidity associated with Friedreich’s ataxia.

"Densitometry on a routine basis should therefore be included in the management of [Friedreich’s ataxia] patients [as] initiation of medical therapy may prevent osteoporosis-related fractures," the researchers said.

No conflicts of interest associated with the study were declared.

SYDNEY, AUSTRALIA – Friedreich’s ataxia patients may be at greater risk of osteopenia and osteoporotic fractures, according to a study showing significant decreases in bone mineral density at key sites such as the femoral neck.

Data presented in a poster at the international congress of Parkinson’s Disease and Movement Disorders also showed a correlation between Friedreich’s ataxia disease severity measures and bone mineral density measures.

Dr. Wolfgang Nachbauer of the department of neurology at Innsbruck (Austria) Medical University and his colleagues measured bone mineral density of the femur, lumbar vertebral column, radius, and ulna, using dual-energy x-ray absorptiometry in 20 patients with Friedreich’s ataxia. Mean age of the patients was 39.4 years.

They found 45% of patients (9 of 20) had osteoporosis at the femur, and 20% (4 of 20) had osteopenia at the same site, while bone mineral density measurements of the lumbar vertebral column showed osteopenia in 30% (6 of 20) and osteoporosis in 10% (2 of 20). Seven patients (35%) had osteopenia in the forearm.

Dr. Nachbauer said this was the first study exploring the incidence of osteopenia and osteoporosis in patients with this disorder.

"We observed clinically some pathological fractures within our Friedreich’s ataxia patients and together with the known action of the iron metabolism it made us think there could be an increased prevalence of osteoporosis and osteopenia with Friedreich’s ataxia," Dr. Nachbauer said in an interview.

Friedreich’s ataxia is a neurodegenerative disorder caused by a mutation in the frataxin gene, which codes for a protein involved in mitochondrial oxidative metabolism and iron homeostasis. Nonneurologic manifestations of Friedreich’s ataxia include scoliosis and foot deformities.

The study found that the most significant decreases in bone mineral density were at the femoral neck site, which is also a common site for hip fracture.

The researchers also examined the correlation between degree of bone mineral density loss and clinical indicators of disease severity in Friedreich’s ataxia. They found a significant, negative association between bone mineral density measurements at the femoral neck and scores on the Scale for the Assessment and Rating of Ataxia (SARA) and the length of GAA allele repeats in the frataxin gene – the defining feature of Friedreich’s ataxia.

"We also used the FRAX score, which is the score for the risk of pathological fractures within the next 10 years and also this score was increased in Friedreich’s ataxia patients," Dr. Nachbauer said.

While there were no significant interactions between potential confounders such as age and body mass index, the study found that wheelchair-bound patients had significantly lower bone density, compared with mobile patients.

The findings offer an opportunity for early intervention to address what may be a significant comorbidity associated with Friedreich’s ataxia.

"Densitometry on a routine basis should therefore be included in the management of [Friedreich’s ataxia] patients [as] initiation of medical therapy may prevent osteoporosis-related fractures," the researchers said.

No conflicts of interest associated with the study were declared.

SYDNEY, AUSTRALIA – Friedreich’s ataxia patients may be at greater risk of osteopenia and osteoporotic fractures, according to a study showing significant decreases in bone mineral density at key sites such as the femoral neck.

Data presented in a poster at the international congress of Parkinson’s Disease and Movement Disorders also showed a correlation between Friedreich’s ataxia disease severity measures and bone mineral density measures.

Dr. Wolfgang Nachbauer of the department of neurology at Innsbruck (Austria) Medical University and his colleagues measured bone mineral density of the femur, lumbar vertebral column, radius, and ulna, using dual-energy x-ray absorptiometry in 20 patients with Friedreich’s ataxia. Mean age of the patients was 39.4 years.

They found 45% of patients (9 of 20) had osteoporosis at the femur, and 20% (4 of 20) had osteopenia at the same site, while bone mineral density measurements of the lumbar vertebral column showed osteopenia in 30% (6 of 20) and osteoporosis in 10% (2 of 20). Seven patients (35%) had osteopenia in the forearm.

Dr. Nachbauer said this was the first study exploring the incidence of osteopenia and osteoporosis in patients with this disorder.

"We observed clinically some pathological fractures within our Friedreich’s ataxia patients and together with the known action of the iron metabolism it made us think there could be an increased prevalence of osteoporosis and osteopenia with Friedreich’s ataxia," Dr. Nachbauer said in an interview.

Friedreich’s ataxia is a neurodegenerative disorder caused by a mutation in the frataxin gene, which codes for a protein involved in mitochondrial oxidative metabolism and iron homeostasis. Nonneurologic manifestations of Friedreich’s ataxia include scoliosis and foot deformities.

The study found that the most significant decreases in bone mineral density were at the femoral neck site, which is also a common site for hip fracture.

The researchers also examined the correlation between degree of bone mineral density loss and clinical indicators of disease severity in Friedreich’s ataxia. They found a significant, negative association between bone mineral density measurements at the femoral neck and scores on the Scale for the Assessment and Rating of Ataxia (SARA) and the length of GAA allele repeats in the frataxin gene – the defining feature of Friedreich’s ataxia.

"We also used the FRAX score, which is the score for the risk of pathological fractures within the next 10 years and also this score was increased in Friedreich’s ataxia patients," Dr. Nachbauer said.

While there were no significant interactions between potential confounders such as age and body mass index, the study found that wheelchair-bound patients had significantly lower bone density, compared with mobile patients.

The findings offer an opportunity for early intervention to address what may be a significant comorbidity associated with Friedreich’s ataxia.

"Densitometry on a routine basis should therefore be included in the management of [Friedreich’s ataxia] patients [as] initiation of medical therapy may prevent osteoporosis-related fractures," the researchers said.

No conflicts of interest associated with the study were declared.

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Taking 800 IU/day of vitamin D₃ supplements for 1 year pushed serum levels into acceptable ranges in 98% of postmenopausal white women with vitamin D insufficiency, and 600 IU/day may work just as well, a study of 163 patients found.

The study was the first long-term, randomized, double-blind placebo-controlled comparison of multiple dosages of vitamin D supplements, Dr. Adarsh J. Sai and his associates reported at the annual meeting of the American College of Physicians. Many trials of vitamin D supplementation in osteoporotic women studied mainly single dosages.

Participants started out with serum levels of 25 hydroxyvitamin D, or 25-(OH)D, greater than 5 ng/mL but less than 20 ng/mL. The World Health Organization and Institute of Medicine consider normal levels to be above 20 ng/mL(or greater than 50 nmol/L), although the 2011 Endocrine Society guidelines define normal as above 30 ng/mL, he said.

The study randomized participants to daily supplementation with placebo or one of seven doses of vitamin D₃: 400, 800, 1,600, 2,400, 3,200, 4,000, or 4,800 IU/day. They also received calcium citrate supplements based on a 7-day food diary to increase daily calcium intake to 1,200-1,400 mg/day (Ann. Intern. Med. 2012;156:425-37).

Serum 25-(OH)D levels increased to above 20 ng/mL in 98% of women on the 800-IU dose, which is the current recommended dietary allowance of vitamin D to maintain normal serum levels in at least 98% of people, he said. A 600-IU dose, however, could achieve the same blood levels, a modeling analysis predicted, though that dose was not provided to women in the study, said Dr. Sai of Loma Linda (Calif.) University.

Prospective trials are needed to confirm whether 600 IU/day would be sufficient supplementation, he said.

After a year of supplementation, serum 25-(OH)D levels were higher in the 31 women with a normal body mass index (BMI), compared with the 65 overweight women or 76 obese women. The normal-weight women’s serum 25-(OH)D levels were 5 ng/mL higher than those of the overweight women and 7 ng/mL higher than those of the obese women.

Serum parathyroid hormone levels decreased with increasing doses of vitamin D. Hypercalcemia occurred in 9% of patients, and hypercalciuria developed in 33%. No patients developed kidney stones.

"The long-term safety of vitamin D combined with calcium needs to be considered," Dr. Sai said at the meeting. "As a reminder, in the Women’s Health Initiative study of approximately 40,000 women on vitamin D 400 IU plus calcium 2,000 mg, the kidney stones incidence increased by about 20%."

At the start of the study, patients had a mean age of 67 years and a mean body mass index of 30 kg/m². The mean serum 25-(OH)D level was 15 ng/mL. During the study, a mean of 94% of patients adhered to vitamin D supplementation, and 91% adhered to calcium supplementation.

The study excluded women with significant comorbidities, active kidney stone disease, or a body mass index greater than 45 kg/m², and women taking any medications that could interfere with bone or vitamin D metabolism.

The National Institute on Aging funded the study. Dr. Sai reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

The National Osteoporosis Foundation released new 2013 guidelines for the treatment and management of osteoporosis for postmenopausal women and men over the age of 50 years.

Osteoporosis definition

Osteoporosis is defined by a bone mineral density (BMD) measurement (T score) less than or equal to 2.5 standard deviations (SD) below the mean for a young adult reference population, or the occurrence of a hip or vertebral fracture without preceding major trauma. Osteopenia is established by BMD testing showing a T score between 1.0-2.5 SD below a young adult reference population.

Assess patient’s risk for fracture

All postmenopausal women and men above age 50 years should be evaluated for risk of osteoporosis in order to determine the need for BMD testing and/or vertebral imaging. In addition, all patients should be evaluated for their risk of falling, since the majority of osteoporosis-related fractures occur because of a fall.

The WHO FRAX tool, may be used in order to calculate the 10-year probability of a hip fracture and the 10-year probability of a major osteoporotic fracture (clinical vertebral, hip, forearm or proximal humerus fracture). Risk of fracture can be calculated either with or without availability of BMD. The 10-year probability of fracture can be used to determine the need for pharmacologic treatment.

Diagnosis

Bone mineral density testing

Dual-energy x-ray absorptiometry (DXA) imaging of the hip and spine can diagnose or confirm osteoporosis. Testing should be considered in:

• Women aged 65 years and older and men 70 years of age and older, regardless of clinical risk factors.

• Patients of either sex who are aged between 50-69 years with clinical risk factors.

• Patients with a fracture after age 50 years.

• And patients with conditions (for example, rheumatoid arthritis) or on medications (for example, glucocorticoids) associated with low bone mass or bone loss.

Vertebral imaging

A single vertebral fracture increases the risk of subsequent vertebral and hip fractures, is consistent with the diagnosis of osteoporosis, and is an indication for pharmacologic treatment regardless of BMD. New to these guidelines is a recommendation for a proactive screening effort for vertebral fractures using lateral thoracic and lumbar spine x-ray or by lateral vertebral fracture assessment (VFA). Indications for vertebral imaging are:

• Women aged 65 years and older and men aged 70 years and older if T score is –1.5 or below.

• Women aged 70 years and men age 80 years and older.

• Postmenopausal women and men aged 50 years and older with a low trauma fracture.

• And/or postmenopausal women and men aged 50-69 years if there is height loss of 1.5 inches or more or ongoing long-term glucocorticoid treatment.

Markers of bone turnover

Biochemical markers of bone turnover are divided into two types:

• Markers of bone remodeling – serum C-telopeptide (CTx) and urinary N-telopeptide (NTx)

• Formation markers-serum bone-specific alkaline phosphatase (BSAP), osteocalcin (OC), and aminoterminal propeptide of type 1 procollagen (P1NP)]

Markers should be collected as fasting morning specimens and may be helpful in predicting risk of fracture and extend of fracture risk reduction when repeated after 3-6 months of pharmacologic therapy.

General recommendations

Vitamin D and calcium: A diet rich in vitamin D and calcium is an inexpensive way to prevent bone mineral density loss. Fruits, vegetables, low-fat dairy, and sunlight are great sources. If dietary supplementation is required, men aged 50-70 years should consume 1,000 mg of calcium/day and women over 51 years old should have 1,200 mg of calcium daily. Both men and women over 50 years should have 800-1,000 IU of vitamin D daily.

Treat vitamin D deficiencies: Supplementation should be adequate to achieve serum levels of 30ng/mL (75nmol/L).

Decreased alcohol use, smoking cessation, exercise, and fall prevention: Smoking cessation should be strongly advised. Moderate alcohol intake does not adversely affect bone and may be associated with lower fracture risk, though consuming more than three drinks daily may have an adverse effect on bone health and increases the risk of falling. Weight-bearing and muscle-strengthening exercise improves bone health and decreases the risk of falls. Home assessment for fall prevention for the elderly may decrease the risk of fracture.

Pharmacologic treatments

Treatment should be considered in postmenopausal women and men over 50 years with a hip or vertebral fracture; T score less than or equal to –2.5 at femoral neck, total hip or lumbar spine; low bone mass (T score between –1.0 and –2.5) and a 10-year probability of hip fracture greater than or equal to 3% or 10 year probability of major osteoporosis-related fracture greater than or equal to 20%. The antifracture benefits of medications have been studied primarily in postmenopausal women with osteoporosis. Pharmacologic therapy should not be considered life-long and that treatment decisions should be individualized. After 3-5 years of treatment a comprehensive risk assessment should be performed.

The bottom line

Identify risk factors for osteoporosis in postmenopausal women and men over the age of 50 years. Bone mineral density screening is an important part of fracture prevention, and vertebral imaging should now be considered as a part of osteoporosis screening. Pharmacologic treatment can be considered when a nontraumatic fracture is apparent; if the T score is less than or equal to –2.5; or for individuals with an elevated 10-year fracture risk based on WHO model.

• Source: Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2013.

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. Dr. Charles is a second year resident in the Family Medicine Residency Program at Abington Memorial Hospital.

The National Osteoporosis Foundation released new 2013 guidelines for the treatment and management of osteoporosis for postmenopausal women and men over the age of 50 years.

Osteoporosis definition

Osteoporosis is defined by a bone mineral density (BMD) measurement (T score) less than or equal to 2.5 standard deviations (SD) below the mean for a young adult reference population, or the occurrence of a hip or vertebral fracture without preceding major trauma. Osteopenia is established by BMD testing showing a T score between 1.0-2.5 SD below a young adult reference population.

Assess patient’s risk for fracture

All postmenopausal women and men above age 50 years should be evaluated for risk of osteoporosis in order to determine the need for BMD testing and/or vertebral imaging. In addition, all patients should be evaluated for their risk of falling, since the majority of osteoporosis-related fractures occur because of a fall.

The WHO FRAX tool, may be used in order to calculate the 10-year probability of a hip fracture and the 10-year probability of a major osteoporotic fracture (clinical vertebral, hip, forearm or proximal humerus fracture). Risk of fracture can be calculated either with or without availability of BMD. The 10-year probability of fracture can be used to determine the need for pharmacologic treatment.

Diagnosis

Bone mineral density testing

Dual-energy x-ray absorptiometry (DXA) imaging of the hip and spine can diagnose or confirm osteoporosis. Testing should be considered in:

• Women aged 65 years and older and men 70 years of age and older, regardless of clinical risk factors.

• Patients of either sex who are aged between 50-69 years with clinical risk factors.

• Patients with a fracture after age 50 years.

• And patients with conditions (for example, rheumatoid arthritis) or on medications (for example, glucocorticoids) associated with low bone mass or bone loss.

Vertebral imaging

A single vertebral fracture increases the risk of subsequent vertebral and hip fractures, is consistent with the diagnosis of osteoporosis, and is an indication for pharmacologic treatment regardless of BMD. New to these guidelines is a recommendation for a proactive screening effort for vertebral fractures using lateral thoracic and lumbar spine x-ray or by lateral vertebral fracture assessment (VFA). Indications for vertebral imaging are:

• Women aged 65 years and older and men aged 70 years and older if T score is –1.5 or below.

• Women aged 70 years and men age 80 years and older.

• Postmenopausal women and men aged 50 years and older with a low trauma fracture.

• And/or postmenopausal women and men aged 50-69 years if there is height loss of 1.5 inches or more or ongoing long-term glucocorticoid treatment.

Markers of bone turnover

Biochemical markers of bone turnover are divided into two types:

• Markers of bone remodeling – serum C-telopeptide (CTx) and urinary N-telopeptide (NTx)

• Formation markers-serum bone-specific alkaline phosphatase (BSAP), osteocalcin (OC), and aminoterminal propeptide of type 1 procollagen (P1NP)]

Markers should be collected as fasting morning specimens and may be helpful in predicting risk of fracture and extend of fracture risk reduction when repeated after 3-6 months of pharmacologic therapy.

General recommendations

Vitamin D and calcium: A diet rich in vitamin D and calcium is an inexpensive way to prevent bone mineral density loss. Fruits, vegetables, low-fat dairy, and sunlight are great sources. If dietary supplementation is required, men aged 50-70 years should consume 1,000 mg of calcium/day and women over 51 years old should have 1,200 mg of calcium daily. Both men and women over 50 years should have 800-1,000 IU of vitamin D daily.

Treat vitamin D deficiencies: Supplementation should be adequate to achieve serum levels of 30ng/mL (75nmol/L).

Decreased alcohol use, smoking cessation, exercise, and fall prevention: Smoking cessation should be strongly advised. Moderate alcohol intake does not adversely affect bone and may be associated with lower fracture risk, though consuming more than three drinks daily may have an adverse effect on bone health and increases the risk of falling. Weight-bearing and muscle-strengthening exercise improves bone health and decreases the risk of falls. Home assessment for fall prevention for the elderly may decrease the risk of fracture.

Pharmacologic treatments

Treatment should be considered in postmenopausal women and men over 50 years with a hip or vertebral fracture; T score less than or equal to –2.5 at femoral neck, total hip or lumbar spine; low bone mass (T score between –1.0 and –2.5) and a 10-year probability of hip fracture greater than or equal to 3% or 10 year probability of major osteoporosis-related fracture greater than or equal to 20%. The antifracture benefits of medications have been studied primarily in postmenopausal women with osteoporosis. Pharmacologic therapy should not be considered life-long and that treatment decisions should be individualized. After 3-5 years of treatment a comprehensive risk assessment should be performed.

The bottom line

Identify risk factors for osteoporosis in postmenopausal women and men over the age of 50 years. Bone mineral density screening is an important part of fracture prevention, and vertebral imaging should now be considered as a part of osteoporosis screening. Pharmacologic treatment can be considered when a nontraumatic fracture is apparent; if the T score is less than or equal to –2.5; or for individuals with an elevated 10-year fracture risk based on WHO model.

• Source: Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2013.

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. Dr. Charles is a second year resident in the Family Medicine Residency Program at Abington Memorial Hospital.

The National Osteoporosis Foundation released new 2013 guidelines for the treatment and management of osteoporosis for postmenopausal women and men over the age of 50 years.

Osteoporosis definition

Osteoporosis is defined by a bone mineral density (BMD) measurement (T score) less than or equal to 2.5 standard deviations (SD) below the mean for a young adult reference population, or the occurrence of a hip or vertebral fracture without preceding major trauma. Osteopenia is established by BMD testing showing a T score between 1.0-2.5 SD below a young adult reference population.

Assess patient’s risk for fracture

All postmenopausal women and men above age 50 years should be evaluated for risk of osteoporosis in order to determine the need for BMD testing and/or vertebral imaging. In addition, all patients should be evaluated for their risk of falling, since the majority of osteoporosis-related fractures occur because of a fall.

The WHO FRAX tool, may be used in order to calculate the 10-year probability of a hip fracture and the 10-year probability of a major osteoporotic fracture (clinical vertebral, hip, forearm or proximal humerus fracture). Risk of fracture can be calculated either with or without availability of BMD. The 10-year probability of fracture can be used to determine the need for pharmacologic treatment.

Diagnosis

Bone mineral density testing

Dual-energy x-ray absorptiometry (DXA) imaging of the hip and spine can diagnose or confirm osteoporosis. Testing should be considered in:

• Women aged 65 years and older and men 70 years of age and older, regardless of clinical risk factors.

• Patients of either sex who are aged between 50-69 years with clinical risk factors.

• Patients with a fracture after age 50 years.

• And patients with conditions (for example, rheumatoid arthritis) or on medications (for example, glucocorticoids) associated with low bone mass or bone loss.

Vertebral imaging

A single vertebral fracture increases the risk of subsequent vertebral and hip fractures, is consistent with the diagnosis of osteoporosis, and is an indication for pharmacologic treatment regardless of BMD. New to these guidelines is a recommendation for a proactive screening effort for vertebral fractures using lateral thoracic and lumbar spine x-ray or by lateral vertebral fracture assessment (VFA). Indications for vertebral imaging are:

• Women aged 65 years and older and men aged 70 years and older if T score is –1.5 or below.

• Women aged 70 years and men age 80 years and older.

• Postmenopausal women and men aged 50 years and older with a low trauma fracture.

• And/or postmenopausal women and men aged 50-69 years if there is height loss of 1.5 inches or more or ongoing long-term glucocorticoid treatment.

Markers of bone turnover

Biochemical markers of bone turnover are divided into two types:

• Markers of bone remodeling – serum C-telopeptide (CTx) and urinary N-telopeptide (NTx)

• Formation markers-serum bone-specific alkaline phosphatase (BSAP), osteocalcin (OC), and aminoterminal propeptide of type 1 procollagen (P1NP)]

Markers should be collected as fasting morning specimens and may be helpful in predicting risk of fracture and extend of fracture risk reduction when repeated after 3-6 months of pharmacologic therapy.

General recommendations

Vitamin D and calcium: A diet rich in vitamin D and calcium is an inexpensive way to prevent bone mineral density loss. Fruits, vegetables, low-fat dairy, and sunlight are great sources. If dietary supplementation is required, men aged 50-70 years should consume 1,000 mg of calcium/day and women over 51 years old should have 1,200 mg of calcium daily. Both men and women over 50 years should have 800-1,000 IU of vitamin D daily.

Treat vitamin D deficiencies: Supplementation should be adequate to achieve serum levels of 30ng/mL (75nmol/L).

Decreased alcohol use, smoking cessation, exercise, and fall prevention: Smoking cessation should be strongly advised. Moderate alcohol intake does not adversely affect bone and may be associated with lower fracture risk, though consuming more than three drinks daily may have an adverse effect on bone health and increases the risk of falling. Weight-bearing and muscle-strengthening exercise improves bone health and decreases the risk of falls. Home assessment for fall prevention for the elderly may decrease the risk of fracture.

Pharmacologic treatments

Treatment should be considered in postmenopausal women and men over 50 years with a hip or vertebral fracture; T score less than or equal to –2.5 at femoral neck, total hip or lumbar spine; low bone mass (T score between –1.0 and –2.5) and a 10-year probability of hip fracture greater than or equal to 3% or 10 year probability of major osteoporosis-related fracture greater than or equal to 20%. The antifracture benefits of medications have been studied primarily in postmenopausal women with osteoporosis. Pharmacologic therapy should not be considered life-long and that treatment decisions should be individualized. After 3-5 years of treatment a comprehensive risk assessment should be performed.

The bottom line

Identify risk factors for osteoporosis in postmenopausal women and men over the age of 50 years. Bone mineral density screening is an important part of fracture prevention, and vertebral imaging should now be considered as a part of osteoporosis screening. Pharmacologic treatment can be considered when a nontraumatic fracture is apparent; if the T score is less than or equal to –2.5; or for individuals with an elevated 10-year fracture risk based on WHO model.

• Source: Clinician’s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2013.

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia. Dr. Charles is a second year resident in the Family Medicine Residency Program at Abington Memorial Hospital.

Abdominal and thoracic CT scans obtained for a variety of reasons, such as to assess pain, GI symptoms, or urinary tract complaints, also can be used "opportunistically" to examine lumbar bone mineral density and screen for occult osteoporosis, according to a report in the April 16 issue of the Annals of Internal Medicine.

Abdominal and thoracic CT scans done in routine practice happen to include imaging of the L1 level, which can easily be identified because it is the first non–rib-bearing vertebra. Such scans readily yield data on lumbar bone mineral density (BMD), which is a clinically useful way to diagnose or rule out osteoporosis, said Dr. Perry J. Pickhardt of the department of radiology and his associates at the University of Wisconsin, Madison.

It is important not to confuse this standard CT scanning with quantitative CT (QCT) scanning. QCT "is more labor-intensive; requires an imaging phantom or angle-corrected [region-of-interest] measurement of bone, muscle, and fat at multiple levels; and involves additional money, time, and radiation exposure," they explained.

Unlike dual-energy x-ray absorptiometry (DXA) screening or QCT assessment, "the method that we used requires a negligible amount of training and time; could be applied prospectively by the interpreting radiologist or retrospectively by a radiologist or even nonradiologist; adds no cost; and requires no additional patient time, equipment, software, or radiation exposure," the investigators wrote.

Such incidental CT scans can be assessed retrospectively because they are almost always stored indefinitely in electronic medical records, they noted.

Dr. Pickhardt and his colleagues evaluated CT-derived BMD assessment and compared it against DXA scanning of the hips and spine by identifying 1,867 adults who had undergone the two types of scanning within a 6-month period during the 10-year study interval. They retrieved and reviewed the images, paying particular attention to obvious moderate or severe compression deformities on the CT images, rather than to milder ones, "to avoid ambiguity related to more subjective borderline or mild compression deformities."

The study subjects had a total of 2,063 pairs of CT and DXA assessments that had been performed a median of 67 days apart. A total of 81% of these subjects were women, and the mean age was 59 years.

These patients had undergone abdominal or thoracic CT for a variety of clinical indications, most often for a suspected mass or an oncologic work-up (414 subjects), genitourinary problems (402 subjects), gastrointestinal symptoms (398 subjects), and/or unexplained abdominal pain or symptoms (374 subjects).

Approximately 55% of the CT scans involved intravenous contrast. The use of contrast had no effect on the interpretation of lumbar data on the scans.

The DXA screening identified 22.9% of the study subjects as osteoporotic, 44.8% as osteopenic, and 32.3% as having normal BMD. The CT scans were significantly more sensitive than DXA at distinguishing these three states.

In particular, CT scans identified 119 patients as having osteoporosis, with readily identifiable moderate or severe vertebral fractures, when DXA had classified 62 of these patients as having normal BMD (12 subjects) or only osteopenia (50 subjects).

"Our observations are consistent with prior studies documenting that many patients without osteoporosis diagnosed by DXA will sustain fragility fractures, and suggest that CT attenuation may be a more accurate risk predictor," Dr. Pickhardt and his associates wrote (Ann. Intern. Med. 2013:158:588-95).

If their findings are confirmed in other studies, it may become routine for all abdominal and thoracic CT scans performed for any reason to be used for lumbar BMD assessment as well. "In the future, it may even be possible to incorporate CT ... data into fracture risk assessment tools," they added.

This should result in substantial savings in health care costs since osteoporosis will be diagnosed and treated earlier, before fractures occur, and since it also will reduce the number of costly DXA studies performed.

More than 80 million CT scans were performed in the United States in 2011, "most of which carry potentially useful information about BMD," the researchers noted.

The investigators are now turning their attention to using pelvic CT scans that were obtained for various clinical indications to assess hip BMD. "We are currently investigating the potential for deriving a DXA-equivalent T-score for the hips from standard pelvic CT scans by using a dedicated software tool," Dr. Pickhardt and his associates said.

This study was funded by the National Institutes of Health. None of the investigators reported having any financial conflicts of interest.

Abdominal and thoracic CT scans obtained for a variety of reasons, such as to assess pain, GI symptoms, or urinary tract complaints, also can be used "opportunistically" to examine lumbar bone mineral density and screen for occult osteoporosis, according to a report in the April 16 issue of the Annals of Internal Medicine.

Abdominal and thoracic CT scans done in routine practice happen to include imaging of the L1 level, which can easily be identified because it is the first non–rib-bearing vertebra. Such scans readily yield data on lumbar bone mineral density (BMD), which is a clinically useful way to diagnose or rule out osteoporosis, said Dr. Perry J. Pickhardt of the department of radiology and his associates at the University of Wisconsin, Madison.

It is important not to confuse this standard CT scanning with quantitative CT (QCT) scanning. QCT "is more labor-intensive; requires an imaging phantom or angle-corrected [region-of-interest] measurement of bone, muscle, and fat at multiple levels; and involves additional money, time, and radiation exposure," they explained.

Unlike dual-energy x-ray absorptiometry (DXA) screening or QCT assessment, "the method that we used requires a negligible amount of training and time; could be applied prospectively by the interpreting radiologist or retrospectively by a radiologist or even nonradiologist; adds no cost; and requires no additional patient time, equipment, software, or radiation exposure," the investigators wrote.

Such incidental CT scans can be assessed retrospectively because they are almost always stored indefinitely in electronic medical records, they noted.

Dr. Pickhardt and his colleagues evaluated CT-derived BMD assessment and compared it against DXA scanning of the hips and spine by identifying 1,867 adults who had undergone the two types of scanning within a 6-month period during the 10-year study interval. They retrieved and reviewed the images, paying particular attention to obvious moderate or severe compression deformities on the CT images, rather than to milder ones, "to avoid ambiguity related to more subjective borderline or mild compression deformities."

The study subjects had a total of 2,063 pairs of CT and DXA assessments that had been performed a median of 67 days apart. A total of 81% of these subjects were women, and the mean age was 59 years.

These patients had undergone abdominal or thoracic CT for a variety of clinical indications, most often for a suspected mass or an oncologic work-up (414 subjects), genitourinary problems (402 subjects), gastrointestinal symptoms (398 subjects), and/or unexplained abdominal pain or symptoms (374 subjects).

Approximately 55% of the CT scans involved intravenous contrast. The use of contrast had no effect on the interpretation of lumbar data on the scans.

The DXA screening identified 22.9% of the study subjects as osteoporotic, 44.8% as osteopenic, and 32.3% as having normal BMD. The CT scans were significantly more sensitive than DXA at distinguishing these three states.

In particular, CT scans identified 119 patients as having osteoporosis, with readily identifiable moderate or severe vertebral fractures, when DXA had classified 62 of these patients as having normal BMD (12 subjects) or only osteopenia (50 subjects).

"Our observations are consistent with prior studies documenting that many patients without osteoporosis diagnosed by DXA will sustain fragility fractures, and suggest that CT attenuation may be a more accurate risk predictor," Dr. Pickhardt and his associates wrote (Ann. Intern. Med. 2013:158:588-95).

If their findings are confirmed in other studies, it may become routine for all abdominal and thoracic CT scans performed for any reason to be used for lumbar BMD assessment as well. "In the future, it may even be possible to incorporate CT ... data into fracture risk assessment tools," they added.

This should result in substantial savings in health care costs since osteoporosis will be diagnosed and treated earlier, before fractures occur, and since it also will reduce the number of costly DXA studies performed.

More than 80 million CT scans were performed in the United States in 2011, "most of which carry potentially useful information about BMD," the researchers noted.

The investigators are now turning their attention to using pelvic CT scans that were obtained for various clinical indications to assess hip BMD. "We are currently investigating the potential for deriving a DXA-equivalent T-score for the hips from standard pelvic CT scans by using a dedicated software tool," Dr. Pickhardt and his associates said.

This study was funded by the National Institutes of Health. None of the investigators reported having any financial conflicts of interest.

Abdominal and thoracic CT scans obtained for a variety of reasons, such as to assess pain, GI symptoms, or urinary tract complaints, also can be used "opportunistically" to examine lumbar bone mineral density and screen for occult osteoporosis, according to a report in the April 16 issue of the Annals of Internal Medicine.

Abdominal and thoracic CT scans done in routine practice happen to include imaging of the L1 level, which can easily be identified because it is the first non–rib-bearing vertebra. Such scans readily yield data on lumbar bone mineral density (BMD), which is a clinically useful way to diagnose or rule out osteoporosis, said Dr. Perry J. Pickhardt of the department of radiology and his associates at the University of Wisconsin, Madison.

It is important not to confuse this standard CT scanning with quantitative CT (QCT) scanning. QCT "is more labor-intensive; requires an imaging phantom or angle-corrected [region-of-interest] measurement of bone, muscle, and fat at multiple levels; and involves additional money, time, and radiation exposure," they explained.

Unlike dual-energy x-ray absorptiometry (DXA) screening or QCT assessment, "the method that we used requires a negligible amount of training and time; could be applied prospectively by the interpreting radiologist or retrospectively by a radiologist or even nonradiologist; adds no cost; and requires no additional patient time, equipment, software, or radiation exposure," the investigators wrote.

Such incidental CT scans can be assessed retrospectively because they are almost always stored indefinitely in electronic medical records, they noted.

Dr. Pickhardt and his colleagues evaluated CT-derived BMD assessment and compared it against DXA scanning of the hips and spine by identifying 1,867 adults who had undergone the two types of scanning within a 6-month period during the 10-year study interval. They retrieved and reviewed the images, paying particular attention to obvious moderate or severe compression deformities on the CT images, rather than to milder ones, "to avoid ambiguity related to more subjective borderline or mild compression deformities."

The study subjects had a total of 2,063 pairs of CT and DXA assessments that had been performed a median of 67 days apart. A total of 81% of these subjects were women, and the mean age was 59 years.

These patients had undergone abdominal or thoracic CT for a variety of clinical indications, most often for a suspected mass or an oncologic work-up (414 subjects), genitourinary problems (402 subjects), gastrointestinal symptoms (398 subjects), and/or unexplained abdominal pain or symptoms (374 subjects).

Approximately 55% of the CT scans involved intravenous contrast. The use of contrast had no effect on the interpretation of lumbar data on the scans.

The DXA screening identified 22.9% of the study subjects as osteoporotic, 44.8% as osteopenic, and 32.3% as having normal BMD. The CT scans were significantly more sensitive than DXA at distinguishing these three states.

In particular, CT scans identified 119 patients as having osteoporosis, with readily identifiable moderate or severe vertebral fractures, when DXA had classified 62 of these patients as having normal BMD (12 subjects) or only osteopenia (50 subjects).

"Our observations are consistent with prior studies documenting that many patients without osteoporosis diagnosed by DXA will sustain fragility fractures, and suggest that CT attenuation may be a more accurate risk predictor," Dr. Pickhardt and his associates wrote (Ann. Intern. Med. 2013:158:588-95).

If their findings are confirmed in other studies, it may become routine for all abdominal and thoracic CT scans performed for any reason to be used for lumbar BMD assessment as well. "In the future, it may even be possible to incorporate CT ... data into fracture risk assessment tools," they added.

This should result in substantial savings in health care costs since osteoporosis will be diagnosed and treated earlier, before fractures occur, and since it also will reduce the number of costly DXA studies performed.

More than 80 million CT scans were performed in the United States in 2011, "most of which carry potentially useful information about BMD," the researchers noted.

The investigators are now turning their attention to using pelvic CT scans that were obtained for various clinical indications to assess hip BMD. "We are currently investigating the potential for deriving a DXA-equivalent T-score for the hips from standard pelvic CT scans by using a dedicated software tool," Dr. Pickhardt and his associates said.

This study was funded by the National Institutes of Health. None of the investigators reported having any financial conflicts of interest.