Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis
Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis
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DOI：
10.1056/nejmoa0809493
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发表时间：
2009-08-20
影响因子：
158.5
通讯作者：
Christiansen, Claus
中科院分区：
文献类型：
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作者：
Cummings, Steven R.;San Martin, Javier;Christiansen, Claus
背景：Denosumab是一种全人抗核因子-kappa B受体激活剂配体(RANKL)的单抗，可阻断其与RANK的结合，抑制破骨细胞的发育和活性，减少骨吸收，增加骨密度。由于其独特的作用，Denosumab可能在治疗骨质疏松症方面有用。方法：我们招募了7868名年龄在60岁到90岁之间的女性，她们腰椎或全髋部的骨密度T评分低于-2.5但不低于-4.0。受试者被随机分配到每6个月皮下注射60毫克的地诺单抗或安慰剂，持续36个月。主要终点是新的椎体骨折。次要终点包括非椎体和髋部骨折。结果与安慰剂相比，地诺单抗降低了新的放射学椎体骨折的风险，迪诺单抗组的累积发生率为2.3%，而安慰剂组为7.2%(风险比，0.32；95%可信区间[CI]，0.26至0.41；P
BACKGROUNDDenosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-kappa B ligand (RANKL) that blocks its binding to RANK, inhibiting the development and activity of osteoclasts, decreasing bone resorption, and increasing bone density. Given its unique actions, denosumab may be useful in the treatment of osteoporosis.METHODSWe enrolled 7868 women between the ages of 60 and 90 years who had a bone mineral density T score of less than -2.5 but not less than -4.0 at the lumbar spine or total hip. Subjects were randomly assigned to receive either 60 mg of denosumab or placebo subcutaneously every 6 months for 36 months. The primary end point was new vertebral fracture. Secondary end points included nonvertebral and hip fractures.RESULTSAs compared with placebo, denosumab reduced the risk of new radiographic vertebral fracture, with a cumulative incidence of 2.3% in the denosumab group, versus 7.2% in the placebo group (risk ratio, 0.32; 95% confidence interval [CI], 0.26 to 0.41; P