Treatment with Denosumab Reduces the Incidence of New Vertebral and Hip Fractures in Postmenopausal Women at High Risk
Treatment with Denosumab Reduces the Incidence of New Vertebral and Hip Fractures in Postmenopausal Women at High Risk
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DOI：
10.1210/jc.2010-2784
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发表时间：
2011-06-01
影响因子：
5.8
通讯作者：
McClung, M.
中科院分区：
文献类型：
--
作者：
Boonen, S.;Adachi, J. D.;McClung, M.
背景：FREEDOM（每 6 个月对地诺单抗治疗骨质疏松症进行骨折减少评估）试验表明，地诺单抗可显着降低患有骨质疏松症的绝经后女性的骨折风险。目的：我们评估了地诺单抗对骨折风险较高的女性亚组中新发椎体和髋部骨折发生率的影响。设计：FREEDOM 是一项为期 3 年、随机、双盲、安慰剂对照、第 3 期试验。 受试者和环境：在全球 213 个研究中心招募患有骨质疏松症的绝经后妇女 (N = 7808)。 干预措施： 受试者每 6 个月接受 sc 地诺塞麦 (60 mg) 或安慰剂，每天补充钙 (>= 1000 mg) 和维生素 D (>= 400 IU)。 主要结果指标： 这项事后分析评估了骨折情况具有已知骨折危险因素（包括多发性和/或中度或重度普遍存在的椎体骨折）、年龄为 75 岁或以上和/或股骨颈骨密度 T 得分为 -2.5 或更低的女性的发生率。 结果：与安慰剂相比，地诺单抗显着降低了多发性和/或严重普遍性椎体骨折女性中新发椎体骨折的风险（安慰剂为 16.6%，地诺单抗为 7.5%； P < 0.001）。同样，地诺单抗显着降低了 75 岁或以上受试者的髋部骨折风险（2.3% 安慰剂 vs. 0.9% 地诺单抗；P < 0.01）或基线股骨颈骨矿物质密度 T 分数为 -2.5 或更低的受试者（2.8% 安慰剂 vs. 1.4% 地诺单抗；P = 0.02）。高风险个体的这些风险降低与骨折风险较低的患者中观察到的风险降低一致。结论：狄诺塞麦降低了患有骨质疏松且骨折风险较高的绝经后女性新发椎骨和髋部骨折的发生率。这些结果凸显了狄诺塞麦对不同程度骨折风险的患者具有一致的抗骨折功效。 （临床内分泌代谢杂志 96：1727-1736，2011）
Context: The FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) trial showed denosumab significantly reduced the risk of fractures in postmenopausal women with osteoporosis.Objective: We evaluated the effect of denosumab on the incidence of new vertebral and hip fractures in subgroups of women at higher risk for these fractures.Design: FREEDOM was a 3-yr, randomized, double-blind, placebo-controlled, phase 3 trial.Participants and Setting: Postmenopausal women (N = 7808) with osteoporosis were enrolled at 213 study sites worldwide.Interventions: Subjects received sc denosumab (60 mg) or placebo every 6 months and daily supplements of calcium (>= 1000 mg) and vitamin D (>= 400 IU).Main Outcome Measures: This post hoc analysis evaluated fracture incidence in women with known risk factors for fractures including multiple and/or moderate or severe prevalent vertebral fractures, aged 75 yr or older, and/or femoral neck bone mineral density T-score of -2.5 or less.Results: Compared with placebo, denosumab significantly reduced the risk of new vertebral fractures in women with multiple and/or severe prevalent vertebral fractures (16.6% placebo vs. 7.5% denosumab; P < 0.001). Similarly, denosumab significantly reduced the risk of hip fractures in subjects aged 75 yr or older (2.3% placebo vs. 0.9% denosumab; P < 0.01) or with a baseline femoral neck bone mineral density T-score of -2.5 or less (2.8% placebo vs. 1.4% denosumab; P = 0.02). These risk reductions in higher-risk individuals were consistent with those seen in patients at lower risk of fracture.Conclusions: Denosumab reduced the incidence of new vertebral and hip fractures in postmenopausal women with osteoporosis at higher risk for fracture. These results highlight the consistent antifracture efficacy of denosumab in patients with varying degrees of fracture risk. (J Clin Endocrinol Metab 96: 1727-1736, 2011)