Meunier Pierre J, Roux Christian, Seeman Ego, Ortolani Sergio, Badurski Janusz E, Spector Tim D, Cannata Jorge, Balogh Adam, Lemmel Ernst-Martin, Pors-Nielsen Stig, Rizzoli René, Genant Harry K, Reginster Jean-Yves
Department of Rheumatology and Bone Diseases, Edouard Herriot Hospital, Lyons, France.
N Engl J Med. 2004 Jan 29;350(5):459-68. doi: 10.1056/NEJMoa022436.
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.
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.
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<0.001 for both comparisons). There were no significant differences between the groups in the incidence of serious adverse events.
Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures.
骨质疏松性结构损伤和骨脆性是由骨形成减少和骨吸收增加所致。在一项2期临床试验中，雷奈酸锶是一种口服活性药物，通过增加骨形成和减少骨吸收来使骨重塑分离，已显示可降低椎体骨折风险并增加骨矿物质密度。
为了在一项3期试验中评估雷奈酸锶预防椎体骨折的疗效，我们将1649名患有骨质疏松症（骨矿物质密度低）且至少有一处椎体骨折的绝经后妇女随机分配，让她们每天服用2克口服雷奈酸锶或安慰剂，为期三年。在研究前和研究期间，我们给两组都补充了钙和维生素D。每年拍摄椎体X光片，每六个月进行一次骨矿物质密度测量。
雷奈酸锶组发生新椎体骨折的患者少于安慰剂组，在治疗的第一年风险降低了49%，在三年研究期间降低了41%（相对风险，0.59；95%置信区间，0.48至0.73）。在第36个月时，雷奈酸锶使腰椎的骨矿物质密度增加了14.4%，股骨颈增加了8.3%（两项比较P均<0.001）。两组在严重不良事件发生率方面无显著差异。
用雷奈酸锶治疗绝经后骨质疏松症可导致椎体骨折风险早期且持续降低。
