作者
Felicia Cosman, Daria B Crittenden, Jonathan D Adachi, Neil Binkley, Edward Czerwinski, Serge Ferrari, Lorenz C Hofbauer, Edith Lau, E Michael Lewiecki, Akimitsu Miyauchi, Cristiano AF Zerbini, Cassandra E Milmont, Li Chen, Judy Maddox, Paul D Meisner, Cesar Libanati, Andreas Grauer
发表日期
2016/10/20
期刊
New England Journal of Medicine
卷号
375
期号
16
页码范围
1532-1543
出版商
Massachusetts Medical Society
简介
Background
Romosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption.
Methods
We enrolled 7180 postmenopausal women who had a T score of –2.5 to –3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 months. The coprimary end points were the cumulative incidences of new vertebral fractures at 12 months and 24 months. Secondary end points included clinical (a composite of nonvertebral and symptomatic vertebral) and nonvertebral fractures.
Results
At 12 months, new vertebral fractures had occurred in 16 of 3321 patients (0.5%) in the romosozumab group, as compared with 59 of 3322 (1.8 …
学术搜索中的文章
F Cosman, DB Crittenden, JD Adachi, N Binkley… - New England Journal of Medicine, 2016