New treatment guidelines for osteoporosis from the Endocrine Society now include romosozumab for postmenopausal women with severe osteoporosis. Learn more in this report.
The Endocrine Society has updated treatment guidelines for the treatment of osteoporosis in postmenopausal women to include or alter treatments with romosozumab, selective estrogen receptor modulators, menopausal hormone therapy and tibolone, calcitonin, and calcium and vitamin D.
The update was published in February in The Journal of Clinical Endocrinology & Metabolism. It was issued, in part, due to the recent approval of romosozumab, a monoclonal antibody targeting sclerostin. The treatment was approved by the U.S. Food and Drug Administration, the European Medicines Agency, and Health Canada.
The guideline recommends the use of romosozumab for up to one year for the reduction of vertebral, hip, and nonvertebral fractures in postmenopausal women with severe osteoporosis at very high risk of fracture (defined as T-score less than −2.5 and a prior fracture) or a history of multiple vertebral fractures. The recommended dosage of romosozumab is 210 mg monthly by subcutaneous injection for 12 months.
In postmenopausal women with osteoporosis who have completed a course of romosozumab, treatment with antiresorptive osteoporosis therapies is recommended to maintain bone mineral density gains and reduce fracture risk. The treatment is not recommended for women at high risk of cardiovascular disease and stroke, which includes those with prior myocardial infarction or stroke.
The recommendations are based on a review of data from two large phase three trials that assessed the efficiency of romosozumab in vertebral and nonvertebral fracture risk reduction in post-menopausal women. The FRAME trial showed no imbalances in major adverse cardiovascular events (MACE) or in cardiovascular serious adverse events with romosozumab. However, the ARCH study showed more MACE in the first year with romosozumab, and patients taking romosozumab had a 31 percent higher risk of MACE compared with those taking alendronate.
“The romosozumab label has a boxed warning, recommending careful consideration by the treating clinician as to cardiovascular risk profile in the individual woman who might receive this agent, since clinical trial data from an active comparator study show an imbalance in serious cardiovascular adverse events between romosozumab and alendronate,” the authors wrote.
Other updates for this high risk group includes:
Dolores Shoback, Clifford J Rosen, Dennis M Black, et al. “Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update.” The Journal of Clinical Endocrinology & Metabolism. February 18, 2020. https://doi.org/10.1210/clinem/dgaa048