The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis
The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis
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DOI：
10.1056/nejmoa022436
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发表时间：
2004-01-29
影响因子：
158.5
通讯作者：
Smith, R
中科院分区：
文献类型：
--
作者：
Meunier, PJ;Roux, C;Smith, R
背景：骨质疏松结构损伤和骨脆性是由于骨形成减少和骨吸收增加所致。在2期临床试验中，雷奈酸锶，一种口服活性药物，通过增加骨形成和减少骨吸收来分解骨重建，已被证明可以降低椎骨骨折的风险并增加骨密度。方法：为了在3期试验中评价雷奈酸锶预防椎骨骨折的疗效，我们随机分配了1649名患有骨质疏松症（低骨矿物质密度）和至少一处椎骨骨折的绝经后妇女，每天口服2g雷奈酸锶或安慰剂，为期三年。我们在研究前和研究期间给两组人补充钙和维生素D。每年进行一次脊椎X光片检查，每6个月进行一次骨矿物质密度测量。结果：雷奈酸锶组发生新的脊椎骨折的患者比安慰剂组少，治疗第一年的风险降低了49%，在三年的研究期间降低了41%（相对风险，0.59; 95%置信区间，0.48至0.73）。在36个月时，雷奈酸锶使腰椎骨密度增加14.4%，股骨颈骨密度增加8.3%（P
BACKGROUND:Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption. In a phase 2 clinical trial, strontium ranelate, an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption, has been shown to reduce the risk of vertebral fractures and to increase bone mineral density.METHODS:To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial, we randomly assigned 1649 postmenopausal women with osteoporosis (low bone mineral density) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years. We gave calcium and vitamin D supplements to both groups before and during the study. Vertebral radiographs were obtained annually, and measurements of bone mineral density were performed every six months.RESULTS:New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group, with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period (relative risk, 0.59; 95 percent confidence interval, 0.48 to 0.73). Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck (P