Endocrine Research Unit, San Francisco Veterans Affairs Medical Center, Department of Medicine, San Francisco, California.
Department of Medicine, University of California San Francisco, San Francisco, California.
J Clin Endocrinol Metab. 2020 Mar 1;105(3). doi: 10.1210/clinem/dgaa048.
The objective is to provide an update of the 2019 Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline for the pharmacological management of osteoporosis in postmenopausal women using romosozumab.
We reviewed findings from the meta-analysis and primary clinical trials assessing the efficacy of romosozumab, a monoclonal antibody targeting sclerostin, for the prevention of fractures and concluded that this agent can be considered a treatment option for postmenopausal women at very high risk for osteoporotic fracture. 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.
本指南旨在提供 2019 年绝经后妇女骨质疏松症药物治疗:使用罗莫佐单抗治疗绝经后妇女骨质疏松症的内分泌学会临床实践指南的更新。
我们回顾了针对罗莫佐单抗(一种针对硬化蛋白的单克隆抗体)预防骨折的疗效的荟萃分析和主要临床试验结果,并得出结论,该药物可被视为极高骨折风险的绝经后妇女的一种治疗选择。罗莫佐单抗的标签有一个黑框警告,建议治疗医生仔细考虑可能接受该药物的个体女性的心血管风险状况,因为来自活性对照研究的临床试验数据显示罗莫佐单抗和阿仑膦酸钠之间严重心血管不良事件存在不平衡。