In their randomised, controlled clinical trial, Saag and colleagues compared monthly subcutaneous romosozumab (210 mg) with weekly oral alendronate (70 mg) for the prevention of fractures in postmenopausal women with osteoporosis. In their study, 4903 women received one of the two blinded treatments for 12 months, and then all subsequently received open-label weekly oral alendronate (70 mg). At 24 months' follow-up, the incidence of new vertebral fractures was lower in the romosozumab group than the alendronate group (risk ratio 0·52, 95% CI 0·40–0·66; p<0·001), as was the risk of clinical fracture (hazard ratio [HR] 0·73, 95% CI 0·61–0·88; p<0·001).

中文翻译：

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研究简述

在他们的随机对照临床试验中，Saag及其同事比较了每月皮下注射romosozumab（210 mg）与每周口服阿仑膦酸盐（70 mg）预防绝经后骨质疏松妇女骨折的可能性。在他们的研究中，有4903名妇女接受了两种盲法之一的治疗，为期12个月，然后所有妇女随后接受了每周一次的开放标签口服阿仑膦酸盐（70毫克）治疗。随访24个月，罗莫唑单抗组新椎体骨折的发生率低于阿仑膦酸钠组（风险比0·52，95％CI 0·40-0·66； p <0·001），因为是临床骨折的风险（危险比[HR] 0·73，95％CI 0·61-0·88； p <0·001）。