Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis - A randomized controlled trial
Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis - A randomized controlled trial
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DOI：
10.1001/jama.282.14.1344
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发表时间：
1999-10-13
影响因子：
120.7
通讯作者：
Miller, PD
中科院分区：
文献类型：
--
作者：
Harris, ST;Watts, NB;Miller, PD
利塞膦酸盐是一种有效的双膦酸盐，已被证明在治疗佩吉特骨病和其他代谢性骨病方面有效，但据我们所知，尚未对其治疗绝经后骨质疏松症进行评估。目的探讨利塞膦酸钠对绝经后骨质疏松症患者降低椎体及其他部位骨折风险的疗效和安全性。设计、环境和参与者：在1993年12月至1998年1月期间，北美110个中心中的1个中心招募了2458名年龄小于85岁、基线时至少有一处椎体骨折的绝经后妇女，进行了随机、双盲、安慰剂对照试验。干预措施受试者被随机分配接受利塞膦酸盐（2.5或5mg /d）或安慰剂口服治疗3年。所有受试者接受钙，1000毫克/天，如果25-羟基维生素d基线水平低，则提供维生素d（胆钙化醇，高达500 IU/天）。主要观察指标：通过x线片定量和半定量评估检测椎体新骨折发生率；x线片证实的非椎体骨折发生率和双x线吸收测定法测定的骨密度基线变化。结果利塞膦酸钠2.5 mg/d组用药1年后停用；在安慰剂组和5mg /d的利塞膦酸钠组中，分别有450名和489名受试者完成了全部3年的试验。与安慰剂相比，5 mg/d的利塞膦酸钠治疗在3年内将新椎体骨折的累积发生率降低了41%(95%可信区间[CI]， 18%-58%) （11.3% vs 16.3%； P= 0.003）。一年后观察到骨折发生率为65% (95% CI, 38%-81%) (2.4% vs 6.4%
Context Risedronate, a potent bisphosphonate, has been shown to be effective in the treatment of Paget disease of bone and other metabolic bone diseases but, to our knowledge, it has not been evaluated in the treatment of established postmenopausal osteoporosis. Objective To test the efficacy and safety of daily treatment with risedronate to reduce the risk of vertebral and other fractures in postmenopausal women with established osteoporosis. Design, Setting, and Participants Randomized, double-blind, placebo-controlled trial of 2458 ambulatory postmenopausal women younger than 85 years with at least 1 vertebral fracture at baseline who were enrolled at 1 of 110 centers in North America conducted between December 1993 and January 1998. interventions Subjects were randomly assigned to receive oral treatment for 3 years with risedronate (2.5 or 5 mg/d) or placebo. All subjects received calcium, 1000 mg/d, Vitamin D (cholecalciferol, up to 500 IU/d) was provided if baseline levels of 25-hydroxyvitamin D were low. Main Outcome Measures Incidence of new vertebral fractures as detected by quantitative and semiquantitative assessments of radiographs; incidence of radiographically confirmed nonvertebral fractures and change from baseline in bone mineral density as determined by dual x-ray absorptiometry. Results The 2.5 mg/d of risedronate arm was discontinued after 1 year; in the placebo and 5 mg/d of risedronate arms, 450 and 489 subjects, respectively, completed all 3 years of the trial. Treatment with 5 mg/d of risedronate, compared with placebo, decreased the cumulative incidence of new vertebral fractures by 41% (95% confidence interval [CI], 18%-58%) over 3 years (11.3% vs 16.3%; P=.003). A fracture reduction of 65% (95% CI, 38%-81%) was observed after the first year (2.4% vs 6.4%; P