Endocrine Society Updates 2019 Osteoporosis Guideline
The Endocrine Society has issued a “formal amendment” to its 2019 clinical practice guideline for the pharmacological management of osteoporosis in postmenopausal women.
After reviewing findings from the meta-analysis and primary clinical trials assessing the efficacy of romosozumab, the authors of the 2019 guideline write that romosozumab can now be considered a treatment option for postmenopausal women with very high osteoporotic fracture risk.
Romosozumab, a monoclonal antibody targeting sclerostin, was approved for the prevention of fractures by the US Food and Drug Administration in April 2019. The European Medicines Agency, Health Canada, and other international agencies have also approved romosozumab for this indication.
The authors of the guideline note that the romosozumab label includes a boxed warning, which recommends careful consideration of a woman’s cardiovascular risk profile prior to prescribing this agent. Clinical trial data from an active comparator study of romosozumab and alendronate showed an imbalance in serious cardiovascular adverse events among participants treated with romosozumab compared with alendronate, the authors of the guideline wrote.
Shoback D, Rosen CJ, Black DM, Cheung AM, Murad MH, Eastell R. Pharmacological management of osteoporosis in postmenopausal women: an Endocrine Society guideline update. J Clin Endocrinol Metab. 2020;105(3):dgaa048. https://doi.org/10.1210/clinem/dgaa048.