Romosozumab或Alendronate骨折预防妇女骨质疏松症。

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Saag公斤,彼得森J,布ML, Karaplis AC, Lorentzon M,托马斯•T Maddox J,风扇,梅森尔PD,劳尔

Romosozumab或Alendronate骨折预防妇女骨质疏松症。

郑传经地中海J。2017年10月12日,377 (15):1417 - 1427。doi: 10.1056 / NEJMoa1708322。Epub 2017年9月11日。

PubMed ID

28892457 (在PubMed

]

文摘

背景:Romosozumab是一个结合的单克隆抗体,抑制sclerostin,增加骨形成,减少骨吸收。方法:我们招收了4093名绝经后妇女骨质疏松症和脆弱性骨折随机分配在1:1的比例获得月度皮下romosozumab(210毫克)或每周口服alendronate(70毫克)的盲评12个月,两组非盲alendronate紧随其后。主要终点是新的椎骨折在24个月的累积发病率和临床骨折的累积发病率(nonvertebral和症状性椎骨折)时的主要分析(在临床骨折已证实> / = 330名患者)。次要终点包括nonvertebral和髋部骨折的发生率的主要分析。严重的心血管不良事件,骨坏死的下巴,和非典型股骨骨折被裁决。结果:在一段时间内的24个月,观察新椎骨折风险降低48% romosozumab-to-alendronate组(2046名患者(127)6.2%)比alendronate-to-alendronate组(2047名患者(243)11.9%)(P < 0.001)。临床骨折发生在198年,2046名患者(9.7%)romosozumab-to-alendronate集团与266年的2047名患者(13.0%)在alendronate-to-alendronate集团代表与romosozumab风险降低27% (P < 0.001)。nonvertebral骨折的风险降低了19% romosozumab-to-alendronate组比alendronate-to-alendronate组(178年2046名患者(8.7%)和217年的2047名患者(10.6%);P = 0.04)和髋部骨折的风险降低了38%(41 2047 2046名患者(2.0%)和66名患者(3.2%);P = 0.02)。 Overall adverse events and serious adverse events were balanced between the two groups. During year 1, positively adjudicated serious cardiovascular adverse events were observed more often with romosozumab than with alendronate (50 of 2040 patients [2.5%] vs. 38 of 2014 patients [1.9%]). During the open-label alendronate period, adjudicated events of osteonecrosis of the jaw (1 event each in the romosozumab-to-alendronate and alendronate-to-alendronate groups) and atypical femoral fracture (2 events and 4 events, respectively) were observed. CONCLUSIONS: In postmenopausal women with osteoporosis who were at high risk for fracture, romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower risk of fracture than alendronate alone. (Funded by Amgen and others; ARCH ClinicalTrials.gov number, NCT01631214 .).

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药物

Romosozumab