Kerri Wachter

PHILADELPHIA — Once-monthly oral ibandronate (Boniva) increases spine and hip bone mineral density beyond 2 years, Dr. Paul D. Miller reported in a poster presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Miller, of the department of medicine at the University of Colorado, Denver, and medical director of the Colorado Center for Bone Research, Lakewood, and his colleagues presented 1-year results from the long-term extension phase of the MOBILE (Monthly Oral Ibandronate in Ladies) study. In year 3 of treatment with oral ibandronate, lumbar spine bone mineral density (BMD) increased 1.5% for women receiving 150 mg once monthly and 1.1% for women receiving 100 mg once monthly. In the same period, total hip BMD increased 0.3% in the 150-mg group; total hip BMD did not change for the 100-mg group.

In the MOBILE study, 1,609 postmenopausal women with osteoporosis were randomized to receive 100 mg (single dose), 50 mg plus 50 mg (50-mg doses on 2 consecutive days), or 150 mg (single dose) of monthly oral ibandronate, or 2.5 mg of oral daily ibandronate.

At 2 years, once-monthly oral ibandronate provided superior increases in lumbar spine BMD compared with the daily regimen (Ann. Rheum. Dis. 2006;65:654–61). In 2005, the Food and Drug Administration approved the 150-mg, once-monthly dosage of oral ibandronate.

After 2 years, the MOBILE study was extended for another 3 years. In the extension phase, patients in the 100-mg (single dose) or 150-mg oral ibandronate once-monthly groups maintained these regimens. Patients who were originally randomized to daily treatment or the 50 mg plus 50 mg (50-mg doses on 2 consecutive days) per month regimens were rerandomized to receive either 100 mg once monthly or 150 mg once monthly.

All patients received daily calcium (500 mg) and vitamin D (400 IU) supplements.

For 168 women on 150-mg once-monthly oral ibandronate for 3 years (the 2 years of the MOBILE study and 1 year of the extension study), lumbar spine BMD increased 7.6% from baseline.

Likewise, for 173 women on 100 mg ibandronate, lumbar spine BMD increased 6.4% from baseline. Also, total hip BMD increased 4.1% from baseline in women in the 150-mg group, while it increased 3.4% from baseline in the 100-mg group. Over 3 years, there were also gains of 2.5% and 3.5% from baseline at the femoral neck for the 100-mg and 150-mg groups, respectively. In the same period, there were gains of 5.4% and 6.2% from baseline at the trochanter for the 100-mg and 150-mg groups. The long-term extension study was funded by F. Hoffmann-LaRoche Ltd. and GlaxoSmithKline Inc. Dr. Miller reported receiving funding and consulting fees from both companies.

In a separate poster, Dr. Stuart Silverman, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles, and his colleagues reported on adverse events from the MOBILE study.

A total of 719 women—359 in the 100-mg group and 360 in the 150-mg group—were included in the safety analysis.

The rates of drug-related adverse events were generally low and comparable for the two groups (7.8% for the 100-mg group and 7.5% for the 150-mg group). Only one serious adverse event was considered to be possibly related to treatment with 150-mg oral ibandronate once monthly.

The rates of drug-related adverse events leading to withdrawal were also comparable between the two groups (0.3% in the 100-mg group and 0.8% in the 150-mg group).

Gastrointestinal events have often been cited by patients as a reason for discontinuing oral bisphosphonates. The incidence of upper-GI adverse events was 4.5% and 6.9% in the 100-mg and 150-mg groups, respectively. No serious upper-GI adverse events occurred. The five most common upper-GI adverse events reported were dyspepsia, nausea, upper-abdominal pain, gastritis, and vomiting.

Dr. Silverman reported receiving funding from F. Hoffmann-LaRoche Ltd. and GlaxoSmithKline.

PHILADELPHIA — Once-monthly oral ibandronate (Boniva) increases spine and hip bone mineral density beyond 2 years, Dr. Paul D. Miller reported in a poster presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Miller, of the department of medicine at the University of Colorado, Denver, and medical director of the Colorado Center for Bone Research, Lakewood, and his colleagues presented 1-year results from the long-term extension phase of the MOBILE (Monthly Oral Ibandronate in Ladies) study. In year 3 of treatment with oral ibandronate, lumbar spine bone mineral density (BMD) increased 1.5% for women receiving 150 mg once monthly and 1.1% for women receiving 100 mg once monthly. In the same period, total hip BMD increased 0.3% in the 150-mg group; total hip BMD did not change for the 100-mg group.

In the MOBILE study, 1,609 postmenopausal women with osteoporosis were randomized to receive 100 mg (single dose), 50 mg plus 50 mg (50-mg doses on 2 consecutive days), or 150 mg (single dose) of monthly oral ibandronate, or 2.5 mg of oral daily ibandronate.

At 2 years, once-monthly oral ibandronate provided superior increases in lumbar spine BMD compared with the daily regimen (Ann. Rheum. Dis. 2006;65:654–61). In 2005, the Food and Drug Administration approved the 150-mg, once-monthly dosage of oral ibandronate.

After 2 years, the MOBILE study was extended for another 3 years. In the extension phase, patients in the 100-mg (single dose) or 150-mg oral ibandronate once-monthly groups maintained these regimens. Patients who were originally randomized to daily treatment or the 50 mg plus 50 mg (50-mg doses on 2 consecutive days) per month regimens were rerandomized to receive either 100 mg once monthly or 150 mg once monthly.

All patients received daily calcium (500 mg) and vitamin D (400 IU) supplements.

For 168 women on 150-mg once-monthly oral ibandronate for 3 years (the 2 years of the MOBILE study and 1 year of the extension study), lumbar spine BMD increased 7.6% from baseline.

Likewise, for 173 women on 100 mg ibandronate, lumbar spine BMD increased 6.4% from baseline. Also, total hip BMD increased 4.1% from baseline in women in the 150-mg group, while it increased 3.4% from baseline in the 100-mg group. Over 3 years, there were also gains of 2.5% and 3.5% from baseline at the femoral neck for the 100-mg and 150-mg groups, respectively. In the same period, there were gains of 5.4% and 6.2% from baseline at the trochanter for the 100-mg and 150-mg groups. The long-term extension study was funded by F. Hoffmann-LaRoche Ltd. and GlaxoSmithKline Inc. Dr. Miller reported receiving funding and consulting fees from both companies.

In a separate poster, Dr. Stuart Silverman, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles, and his colleagues reported on adverse events from the MOBILE study.

A total of 719 women—359 in the 100-mg group and 360 in the 150-mg group—were included in the safety analysis.

The rates of drug-related adverse events were generally low and comparable for the two groups (7.8% for the 100-mg group and 7.5% for the 150-mg group). Only one serious adverse event was considered to be possibly related to treatment with 150-mg oral ibandronate once monthly.

The rates of drug-related adverse events leading to withdrawal were also comparable between the two groups (0.3% in the 100-mg group and 0.8% in the 150-mg group).

Gastrointestinal events have often been cited by patients as a reason for discontinuing oral bisphosphonates. The incidence of upper-GI adverse events was 4.5% and 6.9% in the 100-mg and 150-mg groups, respectively. No serious upper-GI adverse events occurred. The five most common upper-GI adverse events reported were dyspepsia, nausea, upper-abdominal pain, gastritis, and vomiting.

Dr. Silverman reported receiving funding from F. Hoffmann-LaRoche Ltd. and GlaxoSmithKline.

PHILADELPHIA — Once-monthly oral ibandronate (Boniva) increases spine and hip bone mineral density beyond 2 years, Dr. Paul D. Miller reported in a poster presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Miller, of the department of medicine at the University of Colorado, Denver, and medical director of the Colorado Center for Bone Research, Lakewood, and his colleagues presented 1-year results from the long-term extension phase of the MOBILE (Monthly Oral Ibandronate in Ladies) study. In year 3 of treatment with oral ibandronate, lumbar spine bone mineral density (BMD) increased 1.5% for women receiving 150 mg once monthly and 1.1% for women receiving 100 mg once monthly. In the same period, total hip BMD increased 0.3% in the 150-mg group; total hip BMD did not change for the 100-mg group.

In the MOBILE study, 1,609 postmenopausal women with osteoporosis were randomized to receive 100 mg (single dose), 50 mg plus 50 mg (50-mg doses on 2 consecutive days), or 150 mg (single dose) of monthly oral ibandronate, or 2.5 mg of oral daily ibandronate.

At 2 years, once-monthly oral ibandronate provided superior increases in lumbar spine BMD compared with the daily regimen (Ann. Rheum. Dis. 2006;65:654–61). In 2005, the Food and Drug Administration approved the 150-mg, once-monthly dosage of oral ibandronate.

After 2 years, the MOBILE study was extended for another 3 years. In the extension phase, patients in the 100-mg (single dose) or 150-mg oral ibandronate once-monthly groups maintained these regimens. Patients who were originally randomized to daily treatment or the 50 mg plus 50 mg (50-mg doses on 2 consecutive days) per month regimens were rerandomized to receive either 100 mg once monthly or 150 mg once monthly.

All patients received daily calcium (500 mg) and vitamin D (400 IU) supplements.

For 168 women on 150-mg once-monthly oral ibandronate for 3 years (the 2 years of the MOBILE study and 1 year of the extension study), lumbar spine BMD increased 7.6% from baseline.

Likewise, for 173 women on 100 mg ibandronate, lumbar spine BMD increased 6.4% from baseline. Also, total hip BMD increased 4.1% from baseline in women in the 150-mg group, while it increased 3.4% from baseline in the 100-mg group. Over 3 years, there were also gains of 2.5% and 3.5% from baseline at the femoral neck for the 100-mg and 150-mg groups, respectively. In the same period, there were gains of 5.4% and 6.2% from baseline at the trochanter for the 100-mg and 150-mg groups. The long-term extension study was funded by F. Hoffmann-LaRoche Ltd. and GlaxoSmithKline Inc. Dr. Miller reported receiving funding and consulting fees from both companies.

In a separate poster, Dr. Stuart Silverman, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles, and his colleagues reported on adverse events from the MOBILE study.

A total of 719 women—359 in the 100-mg group and 360 in the 150-mg group—were included in the safety analysis.

The rates of drug-related adverse events were generally low and comparable for the two groups (7.8% for the 100-mg group and 7.5% for the 150-mg group). Only one serious adverse event was considered to be possibly related to treatment with 150-mg oral ibandronate once monthly.

The rates of drug-related adverse events leading to withdrawal were also comparable between the two groups (0.3% in the 100-mg group and 0.8% in the 150-mg group).

Gastrointestinal events have often been cited by patients as a reason for discontinuing oral bisphosphonates. The incidence of upper-GI adverse events was 4.5% and 6.9% in the 100-mg and 150-mg groups, respectively. No serious upper-GI adverse events occurred. The five most common upper-GI adverse events reported were dyspepsia, nausea, upper-abdominal pain, gastritis, and vomiting.

Dr. Silverman reported receiving funding from F. Hoffmann-LaRoche Ltd. and GlaxoSmithKline.

PHILADELPHIA — Bone geometry appears to confer femoral strength to older black men and may account for some of the differences seen in fracture risk and bone mineral density between older black and white men, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Marc C. Hochberg, professor of medicine and epidemiology at the University of Maryland, Baltimore, and his colleagues used hip structural analysis based on dual-energy x-ray absorptiometry (DXA) scan data to assess parameters of structural geometry of the proximal femur in older black and white men, in an attempt to account for reported differences in hip fracture and hip bone mineral density (BMD).

The researchers used data collected as part of the Baltimore Men's Osteoporosis Study, which recruited 503 white men and 191 black men aged 65 years and older. Black men were slightly heavier (mean weight 87 kg vs. 83 kg for white men) and slightly younger (mean age 72 years vs. 75 years for white men).

The researchers used hip structural analysis to calculate several measures of bone geometry, including the outer diameter, the bone cross-sectional area, the section modulus (an indicator of bending strength), the estimated mean cortical thickness, and the estimated buckling ratio (an estimate of cortical stability in buckling) from DXA hip scans.

Hip structural analysis is an investigational technique used to assess bone geometry in cross-sections of three regions of the proximal femur: across the femoral neck at its narrowest point, in the intertrochanteric region (along the angle bisecting neck and shaft axes), and across the shaft (at a distance of 1.5 times the minimum neck width distal to the axes of intersection).

The geometric parameters were compared between racial groups, using age, height, lean mass, and lean mass fraction as covariates.

BMD was greater for black men at the narrow neck, intertrochanteric, and shaft regions. “Black men had more bone tissue and the bone was narrower, so the tissue was enclosed in a smaller volume,” said Dr. Hochberg.

However, there was no difference in the calculated section modulus (a measure of resistance to axial bending) between white and black men at any of the three sites.

“Since there were no differences in femur bending resistance between the black and the white men, narrower bone, therefore, requires more bone tissue to achieve the same bending strength,” said Dr. Hochberg. Narrower bone with thicker cortices would have a lower buckling ratio and, therefore, higher buckling strength.

Cortical thickness was significantly greater in black men than in white men at all three sites. This did correlate to lower buckling ratios, providing greater protection against buckling failure.

Overall, black men had greater cross-sectional area, which reflects more bone mass. They also had a narrower outer diameter (reflecting smaller bone), thicker cortices, and lower buckling ratios, which reduce the risk of failure on bending at all three sites within the hip. “These geometric factors may explain the lower rate of hip fracture in older black men than in older white men,” said Dr. Hochberg.

PHILADELPHIA — Bone geometry appears to confer femoral strength to older black men and may account for some of the differences seen in fracture risk and bone mineral density between older black and white men, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Marc C. Hochberg, professor of medicine and epidemiology at the University of Maryland, Baltimore, and his colleagues used hip structural analysis based on dual-energy x-ray absorptiometry (DXA) scan data to assess parameters of structural geometry of the proximal femur in older black and white men, in an attempt to account for reported differences in hip fracture and hip bone mineral density (BMD).

The researchers used data collected as part of the Baltimore Men's Osteoporosis Study, which recruited 503 white men and 191 black men aged 65 years and older. Black men were slightly heavier (mean weight 87 kg vs. 83 kg for white men) and slightly younger (mean age 72 years vs. 75 years for white men).

The researchers used hip structural analysis to calculate several measures of bone geometry, including the outer diameter, the bone cross-sectional area, the section modulus (an indicator of bending strength), the estimated mean cortical thickness, and the estimated buckling ratio (an estimate of cortical stability in buckling) from DXA hip scans.

Hip structural analysis is an investigational technique used to assess bone geometry in cross-sections of three regions of the proximal femur: across the femoral neck at its narrowest point, in the intertrochanteric region (along the angle bisecting neck and shaft axes), and across the shaft (at a distance of 1.5 times the minimum neck width distal to the axes of intersection).

The geometric parameters were compared between racial groups, using age, height, lean mass, and lean mass fraction as covariates.

BMD was greater for black men at the narrow neck, intertrochanteric, and shaft regions. “Black men had more bone tissue and the bone was narrower, so the tissue was enclosed in a smaller volume,” said Dr. Hochberg.

However, there was no difference in the calculated section modulus (a measure of resistance to axial bending) between white and black men at any of the three sites.

“Since there were no differences in femur bending resistance between the black and the white men, narrower bone, therefore, requires more bone tissue to achieve the same bending strength,” said Dr. Hochberg. Narrower bone with thicker cortices would have a lower buckling ratio and, therefore, higher buckling strength.

Cortical thickness was significantly greater in black men than in white men at all three sites. This did correlate to lower buckling ratios, providing greater protection against buckling failure.

Overall, black men had greater cross-sectional area, which reflects more bone mass. They also had a narrower outer diameter (reflecting smaller bone), thicker cortices, and lower buckling ratios, which reduce the risk of failure on bending at all three sites within the hip. “These geometric factors may explain the lower rate of hip fracture in older black men than in older white men,” said Dr. Hochberg.

PHILADELPHIA — Bone geometry appears to confer femoral strength to older black men and may account for some of the differences seen in fracture risk and bone mineral density between older black and white men, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Marc C. Hochberg, professor of medicine and epidemiology at the University of Maryland, Baltimore, and his colleagues used hip structural analysis based on dual-energy x-ray absorptiometry (DXA) scan data to assess parameters of structural geometry of the proximal femur in older black and white men, in an attempt to account for reported differences in hip fracture and hip bone mineral density (BMD).

The researchers used data collected as part of the Baltimore Men's Osteoporosis Study, which recruited 503 white men and 191 black men aged 65 years and older. Black men were slightly heavier (mean weight 87 kg vs. 83 kg for white men) and slightly younger (mean age 72 years vs. 75 years for white men).

The researchers used hip structural analysis to calculate several measures of bone geometry, including the outer diameter, the bone cross-sectional area, the section modulus (an indicator of bending strength), the estimated mean cortical thickness, and the estimated buckling ratio (an estimate of cortical stability in buckling) from DXA hip scans.

Hip structural analysis is an investigational technique used to assess bone geometry in cross-sections of three regions of the proximal femur: across the femoral neck at its narrowest point, in the intertrochanteric region (along the angle bisecting neck and shaft axes), and across the shaft (at a distance of 1.5 times the minimum neck width distal to the axes of intersection).

The geometric parameters were compared between racial groups, using age, height, lean mass, and lean mass fraction as covariates.

BMD was greater for black men at the narrow neck, intertrochanteric, and shaft regions. “Black men had more bone tissue and the bone was narrower, so the tissue was enclosed in a smaller volume,” said Dr. Hochberg.

However, there was no difference in the calculated section modulus (a measure of resistance to axial bending) between white and black men at any of the three sites.

“Since there were no differences in femur bending resistance between the black and the white men, narrower bone, therefore, requires more bone tissue to achieve the same bending strength,” said Dr. Hochberg. Narrower bone with thicker cortices would have a lower buckling ratio and, therefore, higher buckling strength.

Cortical thickness was significantly greater in black men than in white men at all three sites. This did correlate to lower buckling ratios, providing greater protection against buckling failure.

Overall, black men had greater cross-sectional area, which reflects more bone mass. They also had a narrower outer diameter (reflecting smaller bone), thicker cortices, and lower buckling ratios, which reduce the risk of failure on bending at all three sites within the hip. “These geometric factors may explain the lower rate of hip fracture in older black men than in older white men,” said Dr. Hochberg.

PHILADELPHIA — Steroidal and nonsteroidal aromatase inhibitors appear to have very similar effects on bone metabolism, which result in increased bone turnover, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Anastrozole, letrozole, and exemestane in this study seem to have similar effects on bone biochemical measurements, and thus bone turnover. … The increase in bone turnover doesn't appear to be significantly different with the steroidal versus nonsteroidal aromatase inhibitors,” said Dr. Eugene McCloskey, a senior clinical lecturer in metabolic bone disease at the University of Sheffield in England.

Aromatase inhibitors have been associated with increased bone turnover, particularly in the setting of adjuvant therapy for breast cancer. Some preclinical studies have suggested that there may be differences between the effect of the steroidal (exemestane) and nonsteroidal (letrozole and anastrozole) aromatase inhibitors on bone turnover.

With the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) trial, Dr. McCloskey and his colleagues compared the effects of these three aromatase inhibitors on safety parameters such as serum markers of bone formation and resorption, lipid profiles, and adrenal function in healthy postmenopausal women with normal bone mineral density at the spine and hip.

Letrozole (Femara) is made by Novartis Pharmaceutical Corp., exemestane (Aromasin) by Pfizer Inc., and anastrozole (Arimidex) by AstraZeneca. The study was sponsored by AstraZeneca, and Dr. McCloskey disclosed that he has received research grants from the company.

In the study, healthy postmenopausal women were randomized to receive letrozole (2.5 mg/day), exemestane (25 mg/day), or anastrozole (1 mg/day) once daily for 24 weeks. The women were followed for another 12 weeks after the end of therapy. Overall, 102 women were randomized and 96 are included in this analysis (32 on letrozole, 34 on exemestane, and 30 on anastrozole).

The researchers measured changes from baseline bone alkaline phosphatase (a formation marker), serum C-telopeptide crosslinks (a marker of resorption), parathyroid hormone, and propeptide of type I procollagen (a marker of formation).

For bone alkaline phosphatase (ALP) all three drugs showed a trend toward increased levels but only exemestane reached statistical significance. However, there was no statistical difference between the three groups.

There was a nonstatistical increase for all three groups in terms of propeptide of type I procollagen (P1NP) but no statistical difference between the groups.

Serum C-telopeptide crosslinks (CTX) levels were also increased in all three groups but there was no significant difference between the groups.

To look at these formation and resorption marker increases in more detail, the researchers calculated the uncoupling index, which is a measure of the difference between formation and resorption. To do this, they calculated z scores for the resorption marker (CTX) and formation markers (ALP and P1NP). Z scores for formation markers were subtracted from z scores for CTX. The results indicated that resorption generally exceeds formation for all three drugs.

In terms of change in parathyroid hormone (PTH) levels, there was a greater decrease with exemestane than with anastrozole. The difference was statistically significant. It's unclear whether there are any significant differences between these drugs in terms of fracture rates, Dr. McCloskey noted.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Steroidal and nonsteroidal aromatase inhibitors appear to have very similar effects on bone metabolism, which result in increased bone turnover, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Anastrozole, letrozole, and exemestane in this study seem to have similar effects on bone biochemical measurements, and thus bone turnover. … The increase in bone turnover doesn't appear to be significantly different with the steroidal versus nonsteroidal aromatase inhibitors,” said Dr. Eugene McCloskey, a senior clinical lecturer in metabolic bone disease at the University of Sheffield in England.

Aromatase inhibitors have been associated with increased bone turnover, particularly in the setting of adjuvant therapy for breast cancer. Some preclinical studies have suggested that there may be differences between the effect of the steroidal (exemestane) and nonsteroidal (letrozole and anastrozole) aromatase inhibitors on bone turnover.

With the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) trial, Dr. McCloskey and his colleagues compared the effects of these three aromatase inhibitors on safety parameters such as serum markers of bone formation and resorption, lipid profiles, and adrenal function in healthy postmenopausal women with normal bone mineral density at the spine and hip.

Letrozole (Femara) is made by Novartis Pharmaceutical Corp., exemestane (Aromasin) by Pfizer Inc., and anastrozole (Arimidex) by AstraZeneca. The study was sponsored by AstraZeneca, and Dr. McCloskey disclosed that he has received research grants from the company.

In the study, healthy postmenopausal women were randomized to receive letrozole (2.5 mg/day), exemestane (25 mg/day), or anastrozole (1 mg/day) once daily for 24 weeks. The women were followed for another 12 weeks after the end of therapy. Overall, 102 women were randomized and 96 are included in this analysis (32 on letrozole, 34 on exemestane, and 30 on anastrozole).

The researchers measured changes from baseline bone alkaline phosphatase (a formation marker), serum C-telopeptide crosslinks (a marker of resorption), parathyroid hormone, and propeptide of type I procollagen (a marker of formation).

For bone alkaline phosphatase (ALP) all three drugs showed a trend toward increased levels but only exemestane reached statistical significance. However, there was no statistical difference between the three groups.

There was a nonstatistical increase for all three groups in terms of propeptide of type I procollagen (P1NP) but no statistical difference between the groups.

Serum C-telopeptide crosslinks (CTX) levels were also increased in all three groups but there was no significant difference between the groups.

To look at these formation and resorption marker increases in more detail, the researchers calculated the uncoupling index, which is a measure of the difference between formation and resorption. To do this, they calculated z scores for the resorption marker (CTX) and formation markers (ALP and P1NP). Z scores for formation markers were subtracted from z scores for CTX. The results indicated that resorption generally exceeds formation for all three drugs.

In terms of change in parathyroid hormone (PTH) levels, there was a greater decrease with exemestane than with anastrozole. The difference was statistically significant. It's unclear whether there are any significant differences between these drugs in terms of fracture rates, Dr. McCloskey noted.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Steroidal and nonsteroidal aromatase inhibitors appear to have very similar effects on bone metabolism, which result in increased bone turnover, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Anastrozole, letrozole, and exemestane in this study seem to have similar effects on bone biochemical measurements, and thus bone turnover. … The increase in bone turnover doesn't appear to be significantly different with the steroidal versus nonsteroidal aromatase inhibitors,” said Dr. Eugene McCloskey, a senior clinical lecturer in metabolic bone disease at the University of Sheffield in England.

Aromatase inhibitors have been associated with increased bone turnover, particularly in the setting of adjuvant therapy for breast cancer. Some preclinical studies have suggested that there may be differences between the effect of the steroidal (exemestane) and nonsteroidal (letrozole and anastrozole) aromatase inhibitors on bone turnover.

With the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) trial, Dr. McCloskey and his colleagues compared the effects of these three aromatase inhibitors on safety parameters such as serum markers of bone formation and resorption, lipid profiles, and adrenal function in healthy postmenopausal women with normal bone mineral density at the spine and hip.

Letrozole (Femara) is made by Novartis Pharmaceutical Corp., exemestane (Aromasin) by Pfizer Inc., and anastrozole (Arimidex) by AstraZeneca. The study was sponsored by AstraZeneca, and Dr. McCloskey disclosed that he has received research grants from the company.

In the study, healthy postmenopausal women were randomized to receive letrozole (2.5 mg/day), exemestane (25 mg/day), or anastrozole (1 mg/day) once daily for 24 weeks. The women were followed for another 12 weeks after the end of therapy. Overall, 102 women were randomized and 96 are included in this analysis (32 on letrozole, 34 on exemestane, and 30 on anastrozole).

The researchers measured changes from baseline bone alkaline phosphatase (a formation marker), serum C-telopeptide crosslinks (a marker of resorption), parathyroid hormone, and propeptide of type I procollagen (a marker of formation).

For bone alkaline phosphatase (ALP) all three drugs showed a trend toward increased levels but only exemestane reached statistical significance. However, there was no statistical difference between the three groups.

There was a nonstatistical increase for all three groups in terms of propeptide of type I procollagen (P1NP) but no statistical difference between the groups.

Serum C-telopeptide crosslinks (CTX) levels were also increased in all three groups but there was no significant difference between the groups.

To look at these formation and resorption marker increases in more detail, the researchers calculated the uncoupling index, which is a measure of the difference between formation and resorption. To do this, they calculated z scores for the resorption marker (CTX) and formation markers (ALP and P1NP). Z scores for formation markers were subtracted from z scores for CTX. The results indicated that resorption generally exceeds formation for all three drugs.

In terms of change in parathyroid hormone (PTH) levels, there was a greater decrease with exemestane than with anastrozole. The difference was statistically significant. It's unclear whether there are any significant differences between these drugs in terms of fracture rates, Dr. McCloskey noted.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Bone geometry appears to confer femoral strength to older black men and may account for some of the differences seen in fracture risk and bone mineral density between older black and white men, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Marc C. Hochberg, professor of medicine and epidemiology at the University of Maryland, Baltimore, and his colleagues used hip structural analysis based on dual-energy x-ray absorptiometry (DXA) scan data to assess parameters of structural geometry of the proximal femur in older black and white men, in an attempt to account for reported differences in hip fracture and hip bone mineral density (BMD).

The researchers used data collected as part of the Baltimore Men's Osteoporosis Study, which recruited 503 white men and 191 black men aged 65 years and older. Black men were slightly heavier (mean weight 87 kg vs. 83 kg for white men) and slightly younger (mean age 72 years vs. 75 years for white men).

The researchers used hip structural analysis to calculate several measures of bone geometry, including the outer diameter, the bone cross-sectional area, the section modulus (an indicator of bending strength), the estimated mean cortical thickness, and the estimated buckling ratio (an estimate of cortical stability in buckling) from DXA hip scans.

Hip structural analysis is an investigational technique used to assess bone geometry in cross-sections of three regions of the proximal femur: across the femoral neck at its narrowest point, in the intertrochanteric region (along the angle bisecting neck and shaft axes), and across the shaft (at a distance of 1.5 times the minimum neck width distal to the axes of intersection).

The geometric parameters were compared between racial groups, using age, height, lean mass, and lean mass fraction as covariates.

BMD was greater for black men at the narrow neck, intertrochanteric, and shaft regions. “Black men had more bone tissue and the bone was narrower, so the tissue was enclosed in a smaller volume,” said Dr. Hochberg.

However, there was no difference in the calculated section modulus (a measure of resistance to axial bending) between white and black men at any of the three sites.

“Since there were no differences in femur bending resistance between the black and the white men, narrower bone, therefore, requires more bone tissue to achieve the same bending strength,” said Dr. Hochberg.

Narrower bone with thicker cortices would have a lower buckling ratio and, therefore, higher buckling strength.

Cortical thickness was significantly greater in black men than in white men at all three sites. This did correlate to lower buckling ratios, providing greater protection against buckling failure.

Overall, black men had greater cross-sectional area, which reflects more bone mass. They also had a narrower outer diameter (reflecting smaller bone), thicker cortices, and lower buckling ratios, which reduce the risk of failure on bending at all three sites within the hip.

“These geometric factors may explain the lower rate of hip fracture in older black men than in older white men,” said Dr. Hochberg.

One limitation of the study is that hip structural analysis evaluates only bone geometry. “It's possible that some of the strength advantage of the femurs of older black men is actually due to stronger bone tissue, rather than more advantageous geometry,” said Dr. Hochberg.

PHILADELPHIA — Bone geometry appears to confer femoral strength to older black men and may account for some of the differences seen in fracture risk and bone mineral density between older black and white men, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Marc C. Hochberg, professor of medicine and epidemiology at the University of Maryland, Baltimore, and his colleagues used hip structural analysis based on dual-energy x-ray absorptiometry (DXA) scan data to assess parameters of structural geometry of the proximal femur in older black and white men, in an attempt to account for reported differences in hip fracture and hip bone mineral density (BMD).

The researchers used data collected as part of the Baltimore Men's Osteoporosis Study, which recruited 503 white men and 191 black men aged 65 years and older. Black men were slightly heavier (mean weight 87 kg vs. 83 kg for white men) and slightly younger (mean age 72 years vs. 75 years for white men).

The researchers used hip structural analysis to calculate several measures of bone geometry, including the outer diameter, the bone cross-sectional area, the section modulus (an indicator of bending strength), the estimated mean cortical thickness, and the estimated buckling ratio (an estimate of cortical stability in buckling) from DXA hip scans.

Hip structural analysis is an investigational technique used to assess bone geometry in cross-sections of three regions of the proximal femur: across the femoral neck at its narrowest point, in the intertrochanteric region (along the angle bisecting neck and shaft axes), and across the shaft (at a distance of 1.5 times the minimum neck width distal to the axes of intersection).

The geometric parameters were compared between racial groups, using age, height, lean mass, and lean mass fraction as covariates.

BMD was greater for black men at the narrow neck, intertrochanteric, and shaft regions. “Black men had more bone tissue and the bone was narrower, so the tissue was enclosed in a smaller volume,” said Dr. Hochberg.

However, there was no difference in the calculated section modulus (a measure of resistance to axial bending) between white and black men at any of the three sites.

“Since there were no differences in femur bending resistance between the black and the white men, narrower bone, therefore, requires more bone tissue to achieve the same bending strength,” said Dr. Hochberg.

Narrower bone with thicker cortices would have a lower buckling ratio and, therefore, higher buckling strength.

Cortical thickness was significantly greater in black men than in white men at all three sites. This did correlate to lower buckling ratios, providing greater protection against buckling failure.

Overall, black men had greater cross-sectional area, which reflects more bone mass. They also had a narrower outer diameter (reflecting smaller bone), thicker cortices, and lower buckling ratios, which reduce the risk of failure on bending at all three sites within the hip.

“These geometric factors may explain the lower rate of hip fracture in older black men than in older white men,” said Dr. Hochberg.

One limitation of the study is that hip structural analysis evaluates only bone geometry. “It's possible that some of the strength advantage of the femurs of older black men is actually due to stronger bone tissue, rather than more advantageous geometry,” said Dr. Hochberg.

PHILADELPHIA — Bone geometry appears to confer femoral strength to older black men and may account for some of the differences seen in fracture risk and bone mineral density between older black and white men, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Marc C. Hochberg, professor of medicine and epidemiology at the University of Maryland, Baltimore, and his colleagues used hip structural analysis based on dual-energy x-ray absorptiometry (DXA) scan data to assess parameters of structural geometry of the proximal femur in older black and white men, in an attempt to account for reported differences in hip fracture and hip bone mineral density (BMD).

The researchers used data collected as part of the Baltimore Men's Osteoporosis Study, which recruited 503 white men and 191 black men aged 65 years and older. Black men were slightly heavier (mean weight 87 kg vs. 83 kg for white men) and slightly younger (mean age 72 years vs. 75 years for white men).

The researchers used hip structural analysis to calculate several measures of bone geometry, including the outer diameter, the bone cross-sectional area, the section modulus (an indicator of bending strength), the estimated mean cortical thickness, and the estimated buckling ratio (an estimate of cortical stability in buckling) from DXA hip scans.

Hip structural analysis is an investigational technique used to assess bone geometry in cross-sections of three regions of the proximal femur: across the femoral neck at its narrowest point, in the intertrochanteric region (along the angle bisecting neck and shaft axes), and across the shaft (at a distance of 1.5 times the minimum neck width distal to the axes of intersection).

The geometric parameters were compared between racial groups, using age, height, lean mass, and lean mass fraction as covariates.

BMD was greater for black men at the narrow neck, intertrochanteric, and shaft regions. “Black men had more bone tissue and the bone was narrower, so the tissue was enclosed in a smaller volume,” said Dr. Hochberg.

However, there was no difference in the calculated section modulus (a measure of resistance to axial bending) between white and black men at any of the three sites.

“Since there were no differences in femur bending resistance between the black and the white men, narrower bone, therefore, requires more bone tissue to achieve the same bending strength,” said Dr. Hochberg.

Narrower bone with thicker cortices would have a lower buckling ratio and, therefore, higher buckling strength.

Cortical thickness was significantly greater in black men than in white men at all three sites. This did correlate to lower buckling ratios, providing greater protection against buckling failure.

Overall, black men had greater cross-sectional area, which reflects more bone mass. They also had a narrower outer diameter (reflecting smaller bone), thicker cortices, and lower buckling ratios, which reduce the risk of failure on bending at all three sites within the hip.

“These geometric factors may explain the lower rate of hip fracture in older black men than in older white men,” said Dr. Hochberg.

One limitation of the study is that hip structural analysis evaluates only bone geometry. “It's possible that some of the strength advantage of the femurs of older black men is actually due to stronger bone tissue, rather than more advantageous geometry,” said Dr. Hochberg.

WILLIAMSBURG, VA. — Thread lifts produce pleasing results because the procedure corrects the downward shift of facial skin with age, something that excisional face-lifts don't address, Dr. Stephen H. Mandy said at a meeting sponsored by Skin Disease Education Foundation.

"Standard face-lifts tend to move the face posteriorly. … The problem [with the aging face] is a vertical descent," said Dr. Mandy, professor of dermatology at the University of Miami.

The descent of the malar fat pad creates the nasolabial folds, the hollow underneath the malar eminence, the jowl, and the prejowl sulcus, Dr. Mandy explained. He estimates that half of his patients have already had a face-lift but are still unhappy with the nasolabial folds and jowls.

Good candidates for this procedure have soft tissue facial ptosis and moderate soft tissue thickness. Without adequate subcutaneous tissue, there is nothing for the barbs to hook into. The threads can also be seen if there is not enough subcutaneous tissue, he said.

The most important portion of the procedure is marking where the threads will be placed. This should be done with the patient in a seated position. Determine where the facial descent is located. "If you have a heavily malar descent, you're going to put two threads to that malar fat pad," Dr. Mandy said. The threads will exit at the nasolabial folds and jowls, improving these two areas, unlike what occurs with a standard face-lift.

There are two types of threads. The two-sided Articulus 400 series (part of the Contour Threads family made by Surgical Specialties Corp.) has two straight needles with a single thread. The barbs face in the opposite direction to the needle on each end, with no barbs in the center of the thread. No knots need to be tied with this thread type. Contour Threads are single threads with barbs facing in the opposite direction to the needle. They are approved for midface, brow, and neck suspension.

The second type of thread, the Featherlift extended-length Aptos thread (Kolster Methods Inc.), has bidirectional barbs and is approved for use in midface suspension surgery to fix the cheek subdermis in an elevated position.

Dr. Mandy has received compensation as a Contour Threads instructor.

For a brow lift, one double thread (Articulus 400 series)—or two single threads (Aptos)—is fixed on each side just behind the hairline, and the ends exit at the eyebrow. A third double thread (or two single threads) comes from behind the hairline at the central forehead to the medial brow on each side. Dr. Mandy said that he always performs Botox injections at the brow 1 week prior to the thread lift. This prevents patients from pulling against the threads and allows healing in the correct position.

For the midface and lower face area, thread placement is highly variable, depending on the individual patient's degree of ptosis. Typically, two single threads or one double will go from the temporal fascia to the angle of the ala and to the corner of the mouth, skewering the malar fat pad. "If there's a significant jowl, [another] thread will come down to the top of the jowl and one to the apex of the jowl—right to the deepest point of the jowl," Dr. Mandy explained.

If a patient has mild ptosis, he will use only one double thread, running from the temporal fascia to the midpoint of the nasolabial fold and to the jowl.

Up to four single threads (or two double) may be used on each side of the neck to tighten this area, but most patients need only two singles (one double). Dr. Mandy frequently performs neck liposuction just prior to thread placement.

The average patient will require six single threads: two on each side for the midface and lower face, and one on each side of the neck.

In terms of sedation, "I use less and less sedation with this procedure," he said. For most patients, he simply administers oral diazepam. If patients are "a little too jittery, I might give them Tylenol with codeine along with that," he said. Local anesthesia is used: 1% lidocaine with epinephrine in a 25-gauge spinal needle. Dr. Mandy typically uses bupivacaine at the entry and exit sites, where the patients have discomfort.

The procedure starts with a 1.5- to 2.0-mm punch biopsy to open the entry point. For the double thread, the threaded needle grabs the fascia and is then passed through the subcutaneous tissue. A sinusoidal placement pattern—moving the needle back and forth while advancing it subcutaneously—will improve strength by increasing the number of barbs anchoring the thread. When the thread is positioned, pull back from the entry point to allow the barbs to "bite" into the tissue, he said.

Next, the tissue between the arms of the threads is bluntly dissected with a sharp-point dissector. The technique is similar to that used with a liposuction cannula. "The beauty of it is that when you do that, you're now creating a biplane face-lift … so that when you lift that skin, you're basically moving the top plane over the bottom plane," Dr. Mandy said. In addition, the tissue healing process occurs all along the "giant flap" of skin.

Finally, the tissue is contoured by basically "walking" the tissue up the threads. The wider the U-bend of the double thread, the better the thread will stay in place.

With the single threads, one end is threaded through a straight needle while the anchoring end is threaded through a curved needle. The curved needles are used to "bite" the fascia, to hold the thread. "The beauty of those is that they really anchor the fascia," he said.

The barbs of the suture will grab gauze, so dental cotton rolls are used around the exit and entry points. After the procedure, Dr. Mandy trims the threads and tapes them in place. This way, he can recorrect if necessary in the first 72 hours.

He uses a chin strap for moderate support and lots of ice postoperatively. He also has patients take 20 mg of prednisone that night and again the next morning. "That greatly reduces facial swelling," he said

Although a thread lift is not a surgical procedure, there is still considerable recovery time involved. "This is not a weekend face-lift. These patients have to anticipate [that it will be] 1 week before they look relatively normal," Dr. Mandy noted.

Don't be concerned if patients look weird with rolls of excess skin immediately after the procedure. "The worse they look post-op, the better they're going to look a month later," he said.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

WILLIAMSBURG, VA. — Thread lifts produce pleasing results because the procedure corrects the downward shift of facial skin with age, something that excisional face-lifts don't address, Dr. Stephen H. Mandy said at a meeting sponsored by Skin Disease Education Foundation.

"Standard face-lifts tend to move the face posteriorly. … The problem [with the aging face] is a vertical descent," said Dr. Mandy, professor of dermatology at the University of Miami.

The descent of the malar fat pad creates the nasolabial folds, the hollow underneath the malar eminence, the jowl, and the prejowl sulcus, Dr. Mandy explained. He estimates that half of his patients have already had a face-lift but are still unhappy with the nasolabial folds and jowls.

Good candidates for this procedure have soft tissue facial ptosis and moderate soft tissue thickness. Without adequate subcutaneous tissue, there is nothing for the barbs to hook into. The threads can also be seen if there is not enough subcutaneous tissue, he said.

The most important portion of the procedure is marking where the threads will be placed. This should be done with the patient in a seated position. Determine where the facial descent is located. "If you have a heavily malar descent, you're going to put two threads to that malar fat pad," Dr. Mandy said. The threads will exit at the nasolabial folds and jowls, improving these two areas, unlike what occurs with a standard face-lift.

There are two types of threads. The two-sided Articulus 400 series (part of the Contour Threads family made by Surgical Specialties Corp.) has two straight needles with a single thread. The barbs face in the opposite direction to the needle on each end, with no barbs in the center of the thread. No knots need to be tied with this thread type. Contour Threads are single threads with barbs facing in the opposite direction to the needle. They are approved for midface, brow, and neck suspension.

The second type of thread, the Featherlift extended-length Aptos thread (Kolster Methods Inc.), has bidirectional barbs and is approved for use in midface suspension surgery to fix the cheek subdermis in an elevated position.

Dr. Mandy has received compensation as a Contour Threads instructor.

For a brow lift, one double thread (Articulus 400 series)—or two single threads (Aptos)—is fixed on each side just behind the hairline, and the ends exit at the eyebrow. A third double thread (or two single threads) comes from behind the hairline at the central forehead to the medial brow on each side. Dr. Mandy said that he always performs Botox injections at the brow 1 week prior to the thread lift. This prevents patients from pulling against the threads and allows healing in the correct position.

For the midface and lower face area, thread placement is highly variable, depending on the individual patient's degree of ptosis. Typically, two single threads or one double will go from the temporal fascia to the angle of the ala and to the corner of the mouth, skewering the malar fat pad. "If there's a significant jowl, [another] thread will come down to the top of the jowl and one to the apex of the jowl—right to the deepest point of the jowl," Dr. Mandy explained.

If a patient has mild ptosis, he will use only one double thread, running from the temporal fascia to the midpoint of the nasolabial fold and to the jowl.

Up to four single threads (or two double) may be used on each side of the neck to tighten this area, but most patients need only two singles (one double). Dr. Mandy frequently performs neck liposuction just prior to thread placement.

The average patient will require six single threads: two on each side for the midface and lower face, and one on each side of the neck.

In terms of sedation, "I use less and less sedation with this procedure," he said. For most patients, he simply administers oral diazepam. If patients are "a little too jittery, I might give them Tylenol with codeine along with that," he said. Local anesthesia is used: 1% lidocaine with epinephrine in a 25-gauge spinal needle. Dr. Mandy typically uses bupivacaine at the entry and exit sites, where the patients have discomfort.

The procedure starts with a 1.5- to 2.0-mm punch biopsy to open the entry point. For the double thread, the threaded needle grabs the fascia and is then passed through the subcutaneous tissue. A sinusoidal placement pattern—moving the needle back and forth while advancing it subcutaneously—will improve strength by increasing the number of barbs anchoring the thread. When the thread is positioned, pull back from the entry point to allow the barbs to "bite" into the tissue, he said.

Next, the tissue between the arms of the threads is bluntly dissected with a sharp-point dissector. The technique is similar to that used with a liposuction cannula. "The beauty of it is that when you do that, you're now creating a biplane face-lift … so that when you lift that skin, you're basically moving the top plane over the bottom plane," Dr. Mandy said. In addition, the tissue healing process occurs all along the "giant flap" of skin.

Finally, the tissue is contoured by basically "walking" the tissue up the threads. The wider the U-bend of the double thread, the better the thread will stay in place.

With the single threads, one end is threaded through a straight needle while the anchoring end is threaded through a curved needle. The curved needles are used to "bite" the fascia, to hold the thread. "The beauty of those is that they really anchor the fascia," he said.

The barbs of the suture will grab gauze, so dental cotton rolls are used around the exit and entry points. After the procedure, Dr. Mandy trims the threads and tapes them in place. This way, he can recorrect if necessary in the first 72 hours.

He uses a chin strap for moderate support and lots of ice postoperatively. He also has patients take 20 mg of prednisone that night and again the next morning. "That greatly reduces facial swelling," he said

Although a thread lift is not a surgical procedure, there is still considerable recovery time involved. "This is not a weekend face-lift. These patients have to anticipate [that it will be] 1 week before they look relatively normal," Dr. Mandy noted.

Don't be concerned if patients look weird with rolls of excess skin immediately after the procedure. "The worse they look post-op, the better they're going to look a month later," he said.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

WILLIAMSBURG, VA. — Thread lifts produce pleasing results because the procedure corrects the downward shift of facial skin with age, something that excisional face-lifts don't address, Dr. Stephen H. Mandy said at a meeting sponsored by Skin Disease Education Foundation.

"Standard face-lifts tend to move the face posteriorly. … The problem [with the aging face] is a vertical descent," said Dr. Mandy, professor of dermatology at the University of Miami.

The descent of the malar fat pad creates the nasolabial folds, the hollow underneath the malar eminence, the jowl, and the prejowl sulcus, Dr. Mandy explained. He estimates that half of his patients have already had a face-lift but are still unhappy with the nasolabial folds and jowls.

Good candidates for this procedure have soft tissue facial ptosis and moderate soft tissue thickness. Without adequate subcutaneous tissue, there is nothing for the barbs to hook into. The threads can also be seen if there is not enough subcutaneous tissue, he said.

The most important portion of the procedure is marking where the threads will be placed. This should be done with the patient in a seated position. Determine where the facial descent is located. "If you have a heavily malar descent, you're going to put two threads to that malar fat pad," Dr. Mandy said. The threads will exit at the nasolabial folds and jowls, improving these two areas, unlike what occurs with a standard face-lift.

There are two types of threads. The two-sided Articulus 400 series (part of the Contour Threads family made by Surgical Specialties Corp.) has two straight needles with a single thread. The barbs face in the opposite direction to the needle on each end, with no barbs in the center of the thread. No knots need to be tied with this thread type. Contour Threads are single threads with barbs facing in the opposite direction to the needle. They are approved for midface, brow, and neck suspension.

The second type of thread, the Featherlift extended-length Aptos thread (Kolster Methods Inc.), has bidirectional barbs and is approved for use in midface suspension surgery to fix the cheek subdermis in an elevated position.

Dr. Mandy has received compensation as a Contour Threads instructor.

For a brow lift, one double thread (Articulus 400 series)—or two single threads (Aptos)—is fixed on each side just behind the hairline, and the ends exit at the eyebrow. A third double thread (or two single threads) comes from behind the hairline at the central forehead to the medial brow on each side. Dr. Mandy said that he always performs Botox injections at the brow 1 week prior to the thread lift. This prevents patients from pulling against the threads and allows healing in the correct position.

For the midface and lower face area, thread placement is highly variable, depending on the individual patient's degree of ptosis. Typically, two single threads or one double will go from the temporal fascia to the angle of the ala and to the corner of the mouth, skewering the malar fat pad. "If there's a significant jowl, [another] thread will come down to the top of the jowl and one to the apex of the jowl—right to the deepest point of the jowl," Dr. Mandy explained.

If a patient has mild ptosis, he will use only one double thread, running from the temporal fascia to the midpoint of the nasolabial fold and to the jowl.

Up to four single threads (or two double) may be used on each side of the neck to tighten this area, but most patients need only two singles (one double). Dr. Mandy frequently performs neck liposuction just prior to thread placement.

The average patient will require six single threads: two on each side for the midface and lower face, and one on each side of the neck.

In terms of sedation, "I use less and less sedation with this procedure," he said. For most patients, he simply administers oral diazepam. If patients are "a little too jittery, I might give them Tylenol with codeine along with that," he said. Local anesthesia is used: 1% lidocaine with epinephrine in a 25-gauge spinal needle. Dr. Mandy typically uses bupivacaine at the entry and exit sites, where the patients have discomfort.

The procedure starts with a 1.5- to 2.0-mm punch biopsy to open the entry point. For the double thread, the threaded needle grabs the fascia and is then passed through the subcutaneous tissue. A sinusoidal placement pattern—moving the needle back and forth while advancing it subcutaneously—will improve strength by increasing the number of barbs anchoring the thread. When the thread is positioned, pull back from the entry point to allow the barbs to "bite" into the tissue, he said.

Next, the tissue between the arms of the threads is bluntly dissected with a sharp-point dissector. The technique is similar to that used with a liposuction cannula. "The beauty of it is that when you do that, you're now creating a biplane face-lift … so that when you lift that skin, you're basically moving the top plane over the bottom plane," Dr. Mandy said. In addition, the tissue healing process occurs all along the "giant flap" of skin.

Finally, the tissue is contoured by basically "walking" the tissue up the threads. The wider the U-bend of the double thread, the better the thread will stay in place.

With the single threads, one end is threaded through a straight needle while the anchoring end is threaded through a curved needle. The curved needles are used to "bite" the fascia, to hold the thread. "The beauty of those is that they really anchor the fascia," he said.

The barbs of the suture will grab gauze, so dental cotton rolls are used around the exit and entry points. After the procedure, Dr. Mandy trims the threads and tapes them in place. This way, he can recorrect if necessary in the first 72 hours.

He uses a chin strap for moderate support and lots of ice postoperatively. He also has patients take 20 mg of prednisone that night and again the next morning. "That greatly reduces facial swelling," he said

Although a thread lift is not a surgical procedure, there is still considerable recovery time involved. "This is not a weekend face-lift. These patients have to anticipate [that it will be] 1 week before they look relatively normal," Dr. Mandy noted.

Don't be concerned if patients look weird with rolls of excess skin immediately after the procedure. "The worse they look post-op, the better they're going to look a month later," he said.

SDEF and this news organization are wholly owned subsidiaries of Elsevier.

PARIS — An investigational anti-inflammatory drug shows promise in reducing the severity of mild to moderate atopic dermatitis, Dr. Karl Beutner said in a poster presentation at the annual meeting of the European Society for Dermatological Research.

A total of 103 patients with mild to moderate atopic dermatitis (body surface area 3%–10%) were randomized to twice-daily treatment with 1% AN0128 (67 patients)—AN0128 has been shown to block inflammatory cytokines in vitro—or the vehicle cream (36 patients) for 4 weeks, wroteDr. Beutner, chief medical officer of Anacor Pharmaceuticals Inc. in Palo Alto, Calif.

Subjects were evaluated with the six-point Investigator's Static Global Assessment at baseline and on days 3, 7, 14, 28, and 35. With the ISGA, patients are rated as clear, almost clear, mild, moderate, severe, or very severe. Treatment success was defined as a rating of clear or almost clear. All other ratings were treatment failures.

At the end of 4 weeks, 51% of the AN0128 group reached a level of clear or almost clear, vs. 37% of controls.

PARIS — An investigational anti-inflammatory drug shows promise in reducing the severity of mild to moderate atopic dermatitis, Dr. Karl Beutner said in a poster presentation at the annual meeting of the European Society for Dermatological Research.

A total of 103 patients with mild to moderate atopic dermatitis (body surface area 3%–10%) were randomized to twice-daily treatment with 1% AN0128 (67 patients)—AN0128 has been shown to block inflammatory cytokines in vitro—or the vehicle cream (36 patients) for 4 weeks, wroteDr. Beutner, chief medical officer of Anacor Pharmaceuticals Inc. in Palo Alto, Calif.

Subjects were evaluated with the six-point Investigator's Static Global Assessment at baseline and on days 3, 7, 14, 28, and 35. With the ISGA, patients are rated as clear, almost clear, mild, moderate, severe, or very severe. Treatment success was defined as a rating of clear or almost clear. All other ratings were treatment failures.

At the end of 4 weeks, 51% of the AN0128 group reached a level of clear or almost clear, vs. 37% of controls.

PARIS — An investigational anti-inflammatory drug shows promise in reducing the severity of mild to moderate atopic dermatitis, Dr. Karl Beutner said in a poster presentation at the annual meeting of the European Society for Dermatological Research.

A total of 103 patients with mild to moderate atopic dermatitis (body surface area 3%–10%) were randomized to twice-daily treatment with 1% AN0128 (67 patients)—AN0128 has been shown to block inflammatory cytokines in vitro—or the vehicle cream (36 patients) for 4 weeks, wroteDr. Beutner, chief medical officer of Anacor Pharmaceuticals Inc. in Palo Alto, Calif.

Subjects were evaluated with the six-point Investigator's Static Global Assessment at baseline and on days 3, 7, 14, 28, and 35. With the ISGA, patients are rated as clear, almost clear, mild, moderate, severe, or very severe. Treatment success was defined as a rating of clear or almost clear. All other ratings were treatment failures.

At the end of 4 weeks, 51% of the AN0128 group reached a level of clear or almost clear, vs. 37% of controls.

PHILADELPHIA — Steroidal and nonsteroidal aromatase inhibitors appear to have very similar effects on bone metabolism, which result in increased bone turnover, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Anastrozole, letrozole, and exemestane in this study seem to have similar effects on bone biochemical measurements, and thus bone turnover. … The increase in bone turnover doesn't appear to be significantly different with the steroidal versus nonsteroidal aromatase inhibitors,” said Dr. Eugene McCloskey, a senior clinical lecturer in metabolic bone disease at the University of Sheffield in England.

Aromatase inhibitors have been associated with increased bone turnover, particularly in the setting of adjuvant therapy for breast cancer. Some preclinical studies have suggested that there may be differences between the effect of the steroidal (exemestane) and nonsteroidal (letrozole and anastrozole) aromatase inhibitors on bone turnover.

With the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) trial, Dr. McCloskey and his colleagues compared the effects of these three aromatase inhibitors on safety parameters such as serum markers of bone formation and resorption, lipid profiles, and adrenal function in healthy postmenopausal women with normal bone mineral density at the spine and hip.

Letrozole (Femara) is made by Novartis Pharmaceutical Corp., exemestane (Aromasin) by Pfizer Inc., and anastrozole (Arimidex) by AstraZeneca. The study was sponsored by AstraZeneca, and Dr. McCloskey disclosed that he has received research grants from the company.

In the study, healthy postmenopausal women were randomized to receive letrozole (2.5 mg/day), exemestane (25 mg/day), or anastrozole (1 mg/day) once daily for 24 weeks. The women were followed for another 12 weeks after the end of therapy. Overall, 102 women were randomized and 96 are included in this analysis (32 on letrozole, 34 on exemestane, and 30 on anastrozole).

The researchers measured changes from baseline bone alkaline phosphatase (a formation marker), serum C-telopeptide crosslinks (a marker of resorption), parathyroid hormone, and propeptide of type I procollagen (a marker of formation).

For bone alkaline phosphatase (ALP) all three drugs showed a trend toward increased levels but only exemestane reached statistical significance. However, there was no statistical difference among the three groups.

There was a nonstatistical increase for all three groups in terms of propeptide of type I procollagen (P1NP) but no statistical difference between the groups.

Serum C-telopeptide crosslinks (CTX) levels were also increased in all three groups but there was no significant difference among the groups.

To look at these formation and resorption marker increases in more detail, the researchers calculated the uncoupling index, which is a measure of the difference between formation and resorption. To do this, they calculated z scores for the resorption marker (CTX) and formation markers (ALP and P1NP). z Scores for formation markers were subtracted from z scores for CTX. The results indicated that resorption generally exceeds formation for all three drugs. With regard to change in parathyroid hormone (PTH) levels, the decrease with exemestane was greater than with anastrozole. The difference was statistically significant.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Steroidal and nonsteroidal aromatase inhibitors appear to have very similar effects on bone metabolism, which result in increased bone turnover, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Anastrozole, letrozole, and exemestane in this study seem to have similar effects on bone biochemical measurements, and thus bone turnover. … The increase in bone turnover doesn't appear to be significantly different with the steroidal versus nonsteroidal aromatase inhibitors,” said Dr. Eugene McCloskey, a senior clinical lecturer in metabolic bone disease at the University of Sheffield in England.

Aromatase inhibitors have been associated with increased bone turnover, particularly in the setting of adjuvant therapy for breast cancer. Some preclinical studies have suggested that there may be differences between the effect of the steroidal (exemestane) and nonsteroidal (letrozole and anastrozole) aromatase inhibitors on bone turnover.

With the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) trial, Dr. McCloskey and his colleagues compared the effects of these three aromatase inhibitors on safety parameters such as serum markers of bone formation and resorption, lipid profiles, and adrenal function in healthy postmenopausal women with normal bone mineral density at the spine and hip.

Letrozole (Femara) is made by Novartis Pharmaceutical Corp., exemestane (Aromasin) by Pfizer Inc., and anastrozole (Arimidex) by AstraZeneca. The study was sponsored by AstraZeneca, and Dr. McCloskey disclosed that he has received research grants from the company.

In the study, healthy postmenopausal women were randomized to receive letrozole (2.5 mg/day), exemestane (25 mg/day), or anastrozole (1 mg/day) once daily for 24 weeks. The women were followed for another 12 weeks after the end of therapy. Overall, 102 women were randomized and 96 are included in this analysis (32 on letrozole, 34 on exemestane, and 30 on anastrozole).

The researchers measured changes from baseline bone alkaline phosphatase (a formation marker), serum C-telopeptide crosslinks (a marker of resorption), parathyroid hormone, and propeptide of type I procollagen (a marker of formation).

For bone alkaline phosphatase (ALP) all three drugs showed a trend toward increased levels but only exemestane reached statistical significance. However, there was no statistical difference among the three groups.

There was a nonstatistical increase for all three groups in terms of propeptide of type I procollagen (P1NP) but no statistical difference between the groups.

Serum C-telopeptide crosslinks (CTX) levels were also increased in all three groups but there was no significant difference among the groups.

To look at these formation and resorption marker increases in more detail, the researchers calculated the uncoupling index, which is a measure of the difference between formation and resorption. To do this, they calculated z scores for the resorption marker (CTX) and formation markers (ALP and P1NP). z Scores for formation markers were subtracted from z scores for CTX. The results indicated that resorption generally exceeds formation for all three drugs. With regard to change in parathyroid hormone (PTH) levels, the decrease with exemestane was greater than with anastrozole. The difference was statistically significant.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Steroidal and nonsteroidal aromatase inhibitors appear to have very similar effects on bone metabolism, which result in increased bone turnover, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

“Anastrozole, letrozole, and exemestane in this study seem to have similar effects on bone biochemical measurements, and thus bone turnover. … The increase in bone turnover doesn't appear to be significantly different with the steroidal versus nonsteroidal aromatase inhibitors,” said Dr. Eugene McCloskey, a senior clinical lecturer in metabolic bone disease at the University of Sheffield in England.

Aromatase inhibitors have been associated with increased bone turnover, particularly in the setting of adjuvant therapy for breast cancer. Some preclinical studies have suggested that there may be differences between the effect of the steroidal (exemestane) and nonsteroidal (letrozole and anastrozole) aromatase inhibitors on bone turnover.

With the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) trial, Dr. McCloskey and his colleagues compared the effects of these three aromatase inhibitors on safety parameters such as serum markers of bone formation and resorption, lipid profiles, and adrenal function in healthy postmenopausal women with normal bone mineral density at the spine and hip.

Letrozole (Femara) is made by Novartis Pharmaceutical Corp., exemestane (Aromasin) by Pfizer Inc., and anastrozole (Arimidex) by AstraZeneca. The study was sponsored by AstraZeneca, and Dr. McCloskey disclosed that he has received research grants from the company.

In the study, healthy postmenopausal women were randomized to receive letrozole (2.5 mg/day), exemestane (25 mg/day), or anastrozole (1 mg/day) once daily for 24 weeks. The women were followed for another 12 weeks after the end of therapy. Overall, 102 women were randomized and 96 are included in this analysis (32 on letrozole, 34 on exemestane, and 30 on anastrozole).

The researchers measured changes from baseline bone alkaline phosphatase (a formation marker), serum C-telopeptide crosslinks (a marker of resorption), parathyroid hormone, and propeptide of type I procollagen (a marker of formation).

For bone alkaline phosphatase (ALP) all three drugs showed a trend toward increased levels but only exemestane reached statistical significance. However, there was no statistical difference among the three groups.

There was a nonstatistical increase for all three groups in terms of propeptide of type I procollagen (P1NP) but no statistical difference between the groups.

Serum C-telopeptide crosslinks (CTX) levels were also increased in all three groups but there was no significant difference among the groups.

To look at these formation and resorption marker increases in more detail, the researchers calculated the uncoupling index, which is a measure of the difference between formation and resorption. To do this, they calculated z scores for the resorption marker (CTX) and formation markers (ALP and P1NP). z Scores for formation markers were subtracted from z scores for CTX. The results indicated that resorption generally exceeds formation for all three drugs. With regard to change in parathyroid hormone (PTH) levels, the decrease with exemestane was greater than with anastrozole. The difference was statistically significant.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — The increased risk of hip fracture in women with lower bone mineral density mainly reflects an increased risk of nonsevere fracture rather than severe fracture, Jane A. Cauley, Dr.P.H., reported at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Cauley, a professor of epidemiology at the University of Pittsburgh, looked for differences in risk factors for severe and nonsevere hip fractures using data from the longitudinal Study of Osteoporotic Fractures, involving 9,704 women aged 65 years and older.

The women were contacted every 4 months by postcard to determine if a hip fracture had occurred. The average follow-up period was 10.5 years.

Preoperative hip radiographs were obtained for 462 women—249 with femoral neck fractures and 213 with intertrochanteric fractures.

The fractures were rated by a single radiologist using the Garden and Kyle systems.

Most hip fractures were classified as severe. Of the femoral neck fractures, 70% were displaced. Of the intertrochanteric fractures, 72% were unstable.

For femoral neck hip fracture, women who went on to have undisplaced fractures had a femoral neck BMD about 7% lower than did women who had a displaced fracture. Among women in the lowest tertile for femoral neck BMD, 58% had displaced fractures, compared with 83% of women in the highest tertile for BMD.

Although lower femoral neck BMD was associated with a greater risk of both types of fracture, a one-standard-deviation decrease in BMD was associated with a more than threefold increased risk of having an undisplaced fracture. There was only an 86% increase in having a displaced fracture.

For intertrochanteric hip fracture, women who went on to have stable fractures had an intertrochanteric BMD about 7% lower than did women who had an unstable fracture. Among women in the lowest tertile for intertrochanteric BMD, 62% had unstable intertrochanteric fractures compared with about 80% of women with higher BMD, said Dr. Cauley.

Again, while low intertrochanteric BMD was associated with an increased risk of both types of intertrochanteric fractures, women with lower BMD had a threefold increase in the risk of having a stable intertrochanteric fracture, compared with an almost twofold increased risk of having an unstable fracture.

One standard deviation decrease in walking speed was a risk factor for femoral neck displaced and undisplaced fractures. A greater height at the age of 25 and steroid and alcohol use were associated with an increased risk for a femoral neck displaced factor.

Dr. Cauley disclosed that she has received research grants from Pfizer Inc., Novartis Pharmaceuticals Corp., Merck & Co, and Eli Lilly & Co. She also has received consulting fees from Novartis.

PHILADELPHIA — The increased risk of hip fracture in women with lower bone mineral density mainly reflects an increased risk of nonsevere fracture rather than severe fracture, Jane A. Cauley, Dr.P.H., reported at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Cauley, a professor of epidemiology at the University of Pittsburgh, looked for differences in risk factors for severe and nonsevere hip fractures using data from the longitudinal Study of Osteoporotic Fractures, involving 9,704 women aged 65 years and older.

The women were contacted every 4 months by postcard to determine if a hip fracture had occurred. The average follow-up period was 10.5 years.

Preoperative hip radiographs were obtained for 462 women—249 with femoral neck fractures and 213 with intertrochanteric fractures.

The fractures were rated by a single radiologist using the Garden and Kyle systems.

Most hip fractures were classified as severe. Of the femoral neck fractures, 70% were displaced. Of the intertrochanteric fractures, 72% were unstable.

For femoral neck hip fracture, women who went on to have undisplaced fractures had a femoral neck BMD about 7% lower than did women who had a displaced fracture. Among women in the lowest tertile for femoral neck BMD, 58% had displaced fractures, compared with 83% of women in the highest tertile for BMD.

Although lower femoral neck BMD was associated with a greater risk of both types of fracture, a one-standard-deviation decrease in BMD was associated with a more than threefold increased risk of having an undisplaced fracture. There was only an 86% increase in having a displaced fracture.

For intertrochanteric hip fracture, women who went on to have stable fractures had an intertrochanteric BMD about 7% lower than did women who had an unstable fracture. Among women in the lowest tertile for intertrochanteric BMD, 62% had unstable intertrochanteric fractures compared with about 80% of women with higher BMD, said Dr. Cauley.

Again, while low intertrochanteric BMD was associated with an increased risk of both types of intertrochanteric fractures, women with lower BMD had a threefold increase in the risk of having a stable intertrochanteric fracture, compared with an almost twofold increased risk of having an unstable fracture.

One standard deviation decrease in walking speed was a risk factor for femoral neck displaced and undisplaced fractures. A greater height at the age of 25 and steroid and alcohol use were associated with an increased risk for a femoral neck displaced factor.

Dr. Cauley disclosed that she has received research grants from Pfizer Inc., Novartis Pharmaceuticals Corp., Merck & Co, and Eli Lilly & Co. She also has received consulting fees from Novartis.

PHILADELPHIA — The increased risk of hip fracture in women with lower bone mineral density mainly reflects an increased risk of nonsevere fracture rather than severe fracture, Jane A. Cauley, Dr.P.H., reported at the annual meeting of the American Society for Bone and Mineral Research.

Dr. Cauley, a professor of epidemiology at the University of Pittsburgh, looked for differences in risk factors for severe and nonsevere hip fractures using data from the longitudinal Study of Osteoporotic Fractures, involving 9,704 women aged 65 years and older.

The women were contacted every 4 months by postcard to determine if a hip fracture had occurred. The average follow-up period was 10.5 years.

Preoperative hip radiographs were obtained for 462 women—249 with femoral neck fractures and 213 with intertrochanteric fractures.

The fractures were rated by a single radiologist using the Garden and Kyle systems.

Most hip fractures were classified as severe. Of the femoral neck fractures, 70% were displaced. Of the intertrochanteric fractures, 72% were unstable.

For femoral neck hip fracture, women who went on to have undisplaced fractures had a femoral neck BMD about 7% lower than did women who had a displaced fracture. Among women in the lowest tertile for femoral neck BMD, 58% had displaced fractures, compared with 83% of women in the highest tertile for BMD.

Although lower femoral neck BMD was associated with a greater risk of both types of fracture, a one-standard-deviation decrease in BMD was associated with a more than threefold increased risk of having an undisplaced fracture. There was only an 86% increase in having a displaced fracture.

For intertrochanteric hip fracture, women who went on to have stable fractures had an intertrochanteric BMD about 7% lower than did women who had an unstable fracture. Among women in the lowest tertile for intertrochanteric BMD, 62% had unstable intertrochanteric fractures compared with about 80% of women with higher BMD, said Dr. Cauley.

Again, while low intertrochanteric BMD was associated with an increased risk of both types of intertrochanteric fractures, women with lower BMD had a threefold increase in the risk of having a stable intertrochanteric fracture, compared with an almost twofold increased risk of having an unstable fracture.

One standard deviation decrease in walking speed was a risk factor for femoral neck displaced and undisplaced fractures. A greater height at the age of 25 and steroid and alcohol use were associated with an increased risk for a femoral neck displaced factor.

Dr. Cauley disclosed that she has received research grants from Pfizer Inc., Novartis Pharmaceuticals Corp., Merck & Co, and Eli Lilly & Co. She also has received consulting fees from Novartis.

PHILADELPHIA — Intermittent intravenous injections of ibandronate continue to improve bone mineral density of the spine and hip at 2 years, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Two-year results from the Dosing IntraVenous Administration (DIVA) study show that IV ibandronate injections every 2 or 3 months were superior to oral daily ibandronate (Boniva) in terms of increased bone mineral density (BMD) at the lumbar spine. The periodic IV injections were also superior to oral daily ibandronate at 1 and 2 years in terms of increased BMD for the total hip, trochanter, and femoral neck.

“IV ibandronate injections improve BMD at the spine and the hip [and] they produce superior BMD gains to oral dosing,” said Dr. E. Michael Lewiecki, osteoporosis director of the New Mexico Clinical Research and Osteoporosis Center and professor of medicine at the University of New Mexico in Albuquerque.

The study was funded in part by F. Hoffmann-La Roche Ltd. and GlaxoSmithKline. Dr. Lewiecki disclosed that he has received research grants from both.

DIVA was a randomized, double-blind, active-control study involving women aged 55–80 years, who were at least 5 years postmenopausal and who had a lumbar spine T score less than −2.5.

Overall 1,395 women were randomized to receive 2-mg IV ibandronate injections every 2 months (454 women), 3 mg IV ibandronate every 3 months (472 women), or 2.5 mg daily oral ibandronate (469 women). All received daily calcium (500 mg) and vitamin D (400 IU) supplements.

The study's primary end point was mean percent change from baseline in lumbar spine BMD at 1 year, and these results were presented at the 2005 annual meeting of the American College of Rheumatology. Secondary end points included mean percent change from baseline in lumbar spine BMD at 2 years, and mean percent change from baseline in total hip, femoral neck, and trochanter BMD at 1 and 2 years.

In early 2006, the Food and Drug Administration approved the 3-mg trimonthly ibandronate IV injection for treating postmenopausal osteoporosis. “These data support the use of the every-3-month regimen in clinical practice,” Dr. Lewiecki said.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Intermittent intravenous injections of ibandronate continue to improve bone mineral density of the spine and hip at 2 years, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Two-year results from the Dosing IntraVenous Administration (DIVA) study show that IV ibandronate injections every 2 or 3 months were superior to oral daily ibandronate (Boniva) in terms of increased bone mineral density (BMD) at the lumbar spine. The periodic IV injections were also superior to oral daily ibandronate at 1 and 2 years in terms of increased BMD for the total hip, trochanter, and femoral neck.

“IV ibandronate injections improve BMD at the spine and the hip [and] they produce superior BMD gains to oral dosing,” said Dr. E. Michael Lewiecki, osteoporosis director of the New Mexico Clinical Research and Osteoporosis Center and professor of medicine at the University of New Mexico in Albuquerque.

The study was funded in part by F. Hoffmann-La Roche Ltd. and GlaxoSmithKline. Dr. Lewiecki disclosed that he has received research grants from both.

DIVA was a randomized, double-blind, active-control study involving women aged 55–80 years, who were at least 5 years postmenopausal and who had a lumbar spine T score less than −2.5.

Overall 1,395 women were randomized to receive 2-mg IV ibandronate injections every 2 months (454 women), 3 mg IV ibandronate every 3 months (472 women), or 2.5 mg daily oral ibandronate (469 women). All received daily calcium (500 mg) and vitamin D (400 IU) supplements.

The study's primary end point was mean percent change from baseline in lumbar spine BMD at 1 year, and these results were presented at the 2005 annual meeting of the American College of Rheumatology. Secondary end points included mean percent change from baseline in lumbar spine BMD at 2 years, and mean percent change from baseline in total hip, femoral neck, and trochanter BMD at 1 and 2 years.

In early 2006, the Food and Drug Administration approved the 3-mg trimonthly ibandronate IV injection for treating postmenopausal osteoporosis. “These data support the use of the every-3-month regimen in clinical practice,” Dr. Lewiecki said.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — Intermittent intravenous injections of ibandronate continue to improve bone mineral density of the spine and hip at 2 years, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

Two-year results from the Dosing IntraVenous Administration (DIVA) study show that IV ibandronate injections every 2 or 3 months were superior to oral daily ibandronate (Boniva) in terms of increased bone mineral density (BMD) at the lumbar spine. The periodic IV injections were also superior to oral daily ibandronate at 1 and 2 years in terms of increased BMD for the total hip, trochanter, and femoral neck.

“IV ibandronate injections improve BMD at the spine and the hip [and] they produce superior BMD gains to oral dosing,” said Dr. E. Michael Lewiecki, osteoporosis director of the New Mexico Clinical Research and Osteoporosis Center and professor of medicine at the University of New Mexico in Albuquerque.

The study was funded in part by F. Hoffmann-La Roche Ltd. and GlaxoSmithKline. Dr. Lewiecki disclosed that he has received research grants from both.

DIVA was a randomized, double-blind, active-control study involving women aged 55–80 years, who were at least 5 years postmenopausal and who had a lumbar spine T score less than −2.5.

Overall 1,395 women were randomized to receive 2-mg IV ibandronate injections every 2 months (454 women), 3 mg IV ibandronate every 3 months (472 women), or 2.5 mg daily oral ibandronate (469 women). All received daily calcium (500 mg) and vitamin D (400 IU) supplements.

The study's primary end point was mean percent change from baseline in lumbar spine BMD at 1 year, and these results were presented at the 2005 annual meeting of the American College of Rheumatology. Secondary end points included mean percent change from baseline in lumbar spine BMD at 2 years, and mean percent change from baseline in total hip, femoral neck, and trochanter BMD at 1 and 2 years.

In early 2006, the Food and Drug Administration approved the 3-mg trimonthly ibandronate IV injection for treating postmenopausal osteoporosis. “These data support the use of the every-3-month regimen in clinical practice,” Dr. Lewiecki said.

ELSEVIER GLOBAL MEDICAL NEWS

PHILADELPHIA — White men and black women are at an increased risk for cardiovascular disease for each standard deviation decrease in volumetric bone mineral density, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

White men have an almost 40% increased risk for each standard deviation decrease in volumetric spine bone mineral density (BMD), while black women appear to have up to a 44% increased risk for each standard deviation decrease in areal BMD, presenting a complicated picture of how bone mass and cardiovascular disease interact with gender and race, said Ghada N. Farhat, Ph.D., an epidemiology research associate at the University of Pittsburgh.

Previous studies have linked low bone mass with increased cardiovascular mortality and morbidity and clinical measures of atherosclerosis. However, many of these studies primarily have involved white women. Less is known about the associations between bone mass and cardiovascular disease (CVD) in men and other races, Dr. Farhat said.

Dr. Farhat and her colleagues performed a longitudinal analysis looking at CVD incidence and bone mass using data from the Health, Aging and Body Composition (Health ABC) study. The Health ABC study was designed to assess the association between changes in body composition and functional decline.

This analysis involved 2,310 adults aged 68–80 years who were included if CVD free at baseline. The cohort was composed of slightly more men (55%) and white patients (58%). Study participants had to be free of disability in activities of daily living and free of functional limitations (defined as any difficulty walking a quarter of a mile or walking up 10 steps without resting) at baseline.

Incidence of CVD was defined as the onset of one or more of the following conditions between study entry and mean follow-up of 5.4 years: coronary heart disease, cerebrovascular disease, peripheral artery disease, and coronary artery disease.

Baseline areal BMD data (obtained by dual-energy x-ray absorptiometry) was available for the total hip, femoral neck, and trochanter in all patients. Baseline volumetric BMD data (obtained by quantitative CT) was available for the trabecular, integral, and cortical spine in a subset of 1,095 patients.

The researchers used Regression analysis to assess associations of BMD measures (per standard deviation decrease) with CVD. They controlled for body mass index, physical activity level, lipids, blood pressure, and other covariates in their analysis models.

During follow-up, 23% of the men and 14% of the women developed CVD. White men had the highest incidence, followed by black men, black women, and lastly white women.

Significant interactions were observed between race and spine volumetric BMD in men. “In black men, there were no associations between volumetric BMD measures and CVD,” Dr. Farhat said. However, in white men, significant associations were observed between spine volumetric BMD measures and CVD. White men had an increased risk of 39% and 38% for each decrease of one standard deviation for integral and cortical spine BMD, respectively.

Significant interactions were also observed between race and all of the areal BMD hip measures among women. “In black women, we observed that all of the areal BMD measures of the hip showed significant associations with CVD,” Dr. Farhat said. In black women, the risk of CVD was increased by 36%, 44%, and 34% for each decrease of one standard deviation in areal BMD of the total hip, femoral neck, and trochanter, respectively. No significant associations between CVD and hip areal BMD measures were observed in white women. Neither IL-6 nor TNF-α nor oxidized LDL cholesterol levels could explain the association of BMD with the incidence of CVD, she said.

Dr. Farhat reported that she had no conflicts of interest.

PHILADELPHIA — White men and black women are at an increased risk for cardiovascular disease for each standard deviation decrease in volumetric bone mineral density, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

White men have an almost 40% increased risk for each standard deviation decrease in volumetric spine bone mineral density (BMD), while black women appear to have up to a 44% increased risk for each standard deviation decrease in areal BMD, presenting a complicated picture of how bone mass and cardiovascular disease interact with gender and race, said Ghada N. Farhat, Ph.D., an epidemiology research associate at the University of Pittsburgh.

Previous studies have linked low bone mass with increased cardiovascular mortality and morbidity and clinical measures of atherosclerosis. However, many of these studies primarily have involved white women. Less is known about the associations between bone mass and cardiovascular disease (CVD) in men and other races, Dr. Farhat said.

Dr. Farhat and her colleagues performed a longitudinal analysis looking at CVD incidence and bone mass using data from the Health, Aging and Body Composition (Health ABC) study. The Health ABC study was designed to assess the association between changes in body composition and functional decline.

This analysis involved 2,310 adults aged 68–80 years who were included if CVD free at baseline. The cohort was composed of slightly more men (55%) and white patients (58%). Study participants had to be free of disability in activities of daily living and free of functional limitations (defined as any difficulty walking a quarter of a mile or walking up 10 steps without resting) at baseline.

Incidence of CVD was defined as the onset of one or more of the following conditions between study entry and mean follow-up of 5.4 years: coronary heart disease, cerebrovascular disease, peripheral artery disease, and coronary artery disease.

Baseline areal BMD data (obtained by dual-energy x-ray absorptiometry) was available for the total hip, femoral neck, and trochanter in all patients. Baseline volumetric BMD data (obtained by quantitative CT) was available for the trabecular, integral, and cortical spine in a subset of 1,095 patients.

The researchers used Regression analysis to assess associations of BMD measures (per standard deviation decrease) with CVD. They controlled for body mass index, physical activity level, lipids, blood pressure, and other covariates in their analysis models.

During follow-up, 23% of the men and 14% of the women developed CVD. White men had the highest incidence, followed by black men, black women, and lastly white women.

Significant interactions were observed between race and spine volumetric BMD in men. “In black men, there were no associations between volumetric BMD measures and CVD,” Dr. Farhat said. However, in white men, significant associations were observed between spine volumetric BMD measures and CVD. White men had an increased risk of 39% and 38% for each decrease of one standard deviation for integral and cortical spine BMD, respectively.

Significant interactions were also observed between race and all of the areal BMD hip measures among women. “In black women, we observed that all of the areal BMD measures of the hip showed significant associations with CVD,” Dr. Farhat said. In black women, the risk of CVD was increased by 36%, 44%, and 34% for each decrease of one standard deviation in areal BMD of the total hip, femoral neck, and trochanter, respectively. No significant associations between CVD and hip areal BMD measures were observed in white women. Neither IL-6 nor TNF-α nor oxidized LDL cholesterol levels could explain the association of BMD with the incidence of CVD, she said.

Dr. Farhat reported that she had no conflicts of interest.

PHILADELPHIA — White men and black women are at an increased risk for cardiovascular disease for each standard deviation decrease in volumetric bone mineral density, according to data presented at the annual meeting of the American Society for Bone and Mineral Research.

White men have an almost 40% increased risk for each standard deviation decrease in volumetric spine bone mineral density (BMD), while black women appear to have up to a 44% increased risk for each standard deviation decrease in areal BMD, presenting a complicated picture of how bone mass and cardiovascular disease interact with gender and race, said Ghada N. Farhat, Ph.D., an epidemiology research associate at the University of Pittsburgh.

Previous studies have linked low bone mass with increased cardiovascular mortality and morbidity and clinical measures of atherosclerosis. However, many of these studies primarily have involved white women. Less is known about the associations between bone mass and cardiovascular disease (CVD) in men and other races, Dr. Farhat said.

Dr. Farhat and her colleagues performed a longitudinal analysis looking at CVD incidence and bone mass using data from the Health, Aging and Body Composition (Health ABC) study. The Health ABC study was designed to assess the association between changes in body composition and functional decline.

This analysis involved 2,310 adults aged 68–80 years who were included if CVD free at baseline. The cohort was composed of slightly more men (55%) and white patients (58%). Study participants had to be free of disability in activities of daily living and free of functional limitations (defined as any difficulty walking a quarter of a mile or walking up 10 steps without resting) at baseline.

Incidence of CVD was defined as the onset of one or more of the following conditions between study entry and mean follow-up of 5.4 years: coronary heart disease, cerebrovascular disease, peripheral artery disease, and coronary artery disease.

Baseline areal BMD data (obtained by dual-energy x-ray absorptiometry) was available for the total hip, femoral neck, and trochanter in all patients. Baseline volumetric BMD data (obtained by quantitative CT) was available for the trabecular, integral, and cortical spine in a subset of 1,095 patients.

The researchers used Regression analysis to assess associations of BMD measures (per standard deviation decrease) with CVD. They controlled for body mass index, physical activity level, lipids, blood pressure, and other covariates in their analysis models.

During follow-up, 23% of the men and 14% of the women developed CVD. White men had the highest incidence, followed by black men, black women, and lastly white women.

Significant interactions were observed between race and spine volumetric BMD in men. “In black men, there were no associations between volumetric BMD measures and CVD,” Dr. Farhat said. However, in white men, significant associations were observed between spine volumetric BMD measures and CVD. White men had an increased risk of 39% and 38% for each decrease of one standard deviation for integral and cortical spine BMD, respectively.

Significant interactions were also observed between race and all of the areal BMD hip measures among women. “In black women, we observed that all of the areal BMD measures of the hip showed significant associations with CVD,” Dr. Farhat said. In black women, the risk of CVD was increased by 36%, 44%, and 34% for each decrease of one standard deviation in areal BMD of the total hip, femoral neck, and trochanter, respectively. No significant associations between CVD and hip areal BMD measures were observed in white women. Neither IL-6 nor TNF-α nor oxidized LDL cholesterol levels could explain the association of BMD with the incidence of CVD, she said.

Dr. Farhat reported that she had no conflicts of interest.