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Postmenopausal women with osteoporosis who take denosumab long-term have increased bone density and a sustained low rate of fractures, according to study results presented at the 2014 joint meeting of the International Society of Endocrinology and the Endocrine Society. Lead study author E. Michael Lewiecki, MD, Clinical Assistant Professor of Medicine at the University of New Mexico School of Medicine in Albuquerque and research colleagues reported that long-term treatment with denosumab was safe and resulted in continuing increases in bone density over the eight years of treatment with persistently low fracture rates.
“This study provides reassurance to physicians and their patients that long-term treatment with denosumab for at least eight years leads to significant increases in bone density and is safe for appropriately selected women with postmenopausal osteoporosis.” He also noted that the overall risk of side effects did not increase over time.
Among the almost 8,000 women originally enrolled in the FREEDOM trial, denosumab reduced their risk of vertebral fractures by 68%, reduced their risk of nonvertebral fractures by 20%, and reduced their risk of hip fractures by 40%, compared with placebo. Women taking the drug had no increase in their overall risk for cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia.
All of the roughly 3,000 women in the long-term extension of the trial took denosumab for up to eight years. Overall, they showed a continued increase in their mean bone mineral density, with a cumulative eight-year gain of 18.4% at the lumbar spine and 8.3% at the total hip, with few fractures and a good safety profile. The tolerability profile of denosumab during this extension phase was consistent with that observed during the initial 3-year FREEDOM trial. At 12 months, denosumab treatment increased bone mineral density (BMD) at the total hip, lumbar spine and/or femoral neck and reduced markers of bone turnover to a significantly greater extent than oral bisphosphonates in women who were essentially bisphosphonate-naive and in those who had switched from alendronate to denosumab treatment.
Postmenopausal women with osteoporosis who take denosumab long-term have increased bone density and a sustained low rate of fractures, according to study results presented at the 2014 joint meeting of the International Society of Endocrinology and the Endocrine Society. Lead study author E. Michael Lewiecki, MD, Clinical Assistant Professor of Medicine at the University of New Mexico School of Medicine in Albuquerque and research colleagues reported that long-term treatment with denosumab was safe and resulted in continuing increases in bone density over the eight years of treatment with persistently low fracture rates.
“This study provides reassurance to physicians and their patients that long-term treatment with denosumab for at least eight years leads to significant increases in bone density and is safe for appropriately selected women with postmenopausal osteoporosis.” He also noted that the overall risk of side effects did not increase over time.
Among the almost 8,000 women originally enrolled in the FREEDOM trial, denosumab reduced their risk of vertebral fractures by 68%, reduced their risk of nonvertebral fractures by 20%, and reduced their risk of hip fractures by 40%, compared with placebo. Women taking the drug had no increase in their overall risk for cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia.
All of the roughly 3,000 women in the long-term extension of the trial took denosumab for up to eight years. Overall, they showed a continued increase in their mean bone mineral density, with a cumulative eight-year gain of 18.4% at the lumbar spine and 8.3% at the total hip, with few fractures and a good safety profile. The tolerability profile of denosumab during this extension phase was consistent with that observed during the initial 3-year FREEDOM trial. At 12 months, denosumab treatment increased bone mineral density (BMD) at the total hip, lumbar spine and/or femoral neck and reduced markers of bone turnover to a significantly greater extent than oral bisphosphonates in women who were essentially bisphosphonate-naive and in those who had switched from alendronate to denosumab treatment.
Postmenopausal women with osteoporosis who take denosumab long-term have increased bone density and a sustained low rate of fractures, according to study results presented at the 2014 joint meeting of the International Society of Endocrinology and the Endocrine Society. Lead study author E. Michael Lewiecki, MD, Clinical Assistant Professor of Medicine at the University of New Mexico School of Medicine in Albuquerque and research colleagues reported that long-term treatment with denosumab was safe and resulted in continuing increases in bone density over the eight years of treatment with persistently low fracture rates.
“This study provides reassurance to physicians and their patients that long-term treatment with denosumab for at least eight years leads to significant increases in bone density and is safe for appropriately selected women with postmenopausal osteoporosis.” He also noted that the overall risk of side effects did not increase over time.
Among the almost 8,000 women originally enrolled in the FREEDOM trial, denosumab reduced their risk of vertebral fractures by 68%, reduced their risk of nonvertebral fractures by 20%, and reduced their risk of hip fractures by 40%, compared with placebo. Women taking the drug had no increase in their overall risk for cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia.
All of the roughly 3,000 women in the long-term extension of the trial took denosumab for up to eight years. Overall, they showed a continued increase in their mean bone mineral density, with a cumulative eight-year gain of 18.4% at the lumbar spine and 8.3% at the total hip, with few fractures and a good safety profile. The tolerability profile of denosumab during this extension phase was consistent with that observed during the initial 3-year FREEDOM trial. At 12 months, denosumab treatment increased bone mineral density (BMD) at the total hip, lumbar spine and/or femoral neck and reduced markers of bone turnover to a significantly greater extent than oral bisphosphonates in women who were essentially bisphosphonate-naive and in those who had switched from alendronate to denosumab treatment.