Ortolani Sergio, Vai Silvia
Center for Metabolic Bone Disease, Division of Endocrinology, Istituto Auxologico Italiano, Via Ariosto 13, 20145 Milan, Italy.
Bone. 2006 Feb;38(2 Suppl 1):19-22. doi: 10.1016/j.bone.2005.10.030.
Strontium ranelate is a new antiosteoporotic treatment with a dual mode of action, both increasing bone formation and decreasing bone resorption, which rebalances bone turnover in favor of bone formation and increases bone strength. The antifracture efficacy of strontium ranelate, 2 g per day orally, in the treatment of postmenopausal osteoporosis has been investigated in a large-scale, international, multicenter, phase 3 program in which more than 7000 patients were recruited. This article deals with the vertebral antifracture efficacy of strontium ranelate in postmenopausal women with osteoporosis. A significant early (after 1 year) and sustained (over 3 years) antifracture efficacy of strontium ranelate, compared with placebo, was demonstrated in patients with prevalent vertebral fracture with reductions in risk of new vertebral fracture of 49% after 1 year (P < 0.001) and 41% over 3 years (P < 0.001). In addition, the relative risk of clinical vertebral fracture was significantly reduced by 52% (P = 0.003) after 1 year and by 38% (P < 0.001) over 3 years in the strontium ranelate group compared with placebo. Strontium ranelate was also demonstrated to significantly decrease the relative risk of vertebral fractures by 45% (P < 0.001) in patients without prevalent vertebral fracture over 3 years, vs. placebo. Bone mineral density was linearly increased during 3 years of treatment with strontium ranelate in comparison with placebo. Strontium ranelate was well tolerated throughout the entire duration of the clinical trials. Thus, strontium ranelate, 2 g per day orally, is a new, effective, and safe treatment for postmenopausal patients with osteoporosis, to reduce the vertebral fracture risk in patients with or without a history of vertebral fracture.
雷奈酸锶是一种新型抗骨质疏松药物，具有双重作用模式，既能增加骨形成又能减少骨吸收，从而重新平衡骨转换，促进骨形成并增强骨强度。在一项大规模、国际多中心3期试验中，招募了7000多名患者，对每日口服2克雷奈酸锶治疗绝经后骨质疏松症的抗骨折疗效进行了研究。本文探讨雷奈酸锶对绝经后骨质疏松症女性的椎体抗骨折疗效。与安慰剂相比，雷奈酸锶在有椎体骨折病史的患者中显示出显著的早期（1年后）和持续（3年以上）抗骨折疗效，1年后新发椎体骨折风险降低49%（P<0.001），3年以上降低41%（P<0.001）。此外，与安慰剂相比，雷奈酸锶组1年后临床椎体骨折相对风险显著降低52%（P=0.003），3年以上降低38%（P<0.001）。在无椎体骨折病史的患者中，与安慰剂相比，雷奈酸锶在3年以上也显示出显著降低椎体骨折相对风险45%（P<0.001）。与安慰剂相比，雷奈酸锶治疗3年期间骨密度呈线性增加。在整个临床试验期间，雷奈酸锶耐受性良好。因此，每日口服2克雷奈酸锶是一种治疗绝经后骨质疏松症患者的新型、有效且安全的药物，可降低有或无椎体骨折病史患者的椎体骨折风险。
