WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, South Yorkshire, UK.
Osteoporos Int. 2011 Aug;22(8):2347-55. doi: 10.1007/s00198-010-1474-0. Epub 2011 Feb 2.
The aim of the present study was to determine the efficacy of strontium ranelate as a function of baseline fracture risk. Treatment with strontium ranelate was associated with a significant 31% decrease in all clinical osteoporotic fractures (vertebral fractures included). Hazard ratios for the effect of strontium ranelate on the fracture outcome did not change significantly with increasing fracture probability.
Two previous studies have suggested that the efficacy of intervention may be greater in the segment of the population at highest fracture risk as assessed by the FRAX(®) algorithms. The aim of the present study was to determine whether the anti-fracture efficacy of strontium ranelate was dependent of the level of fracture risk.
The primary data of the two phase III studies (SOTI and TROPOS) of the effects of strontium ranelate in postmenopausal osteoporosis were combined. Country-specific probabilities were computed using the FRAX(®) tool (version 2.0). The primary outcome variable comprised all clinical osteoporotic fractures (including clinical vertebral fractures). Interactions between fracture probability and efficacy were explored by Poisson regression.
The 10-year probability of major osteoporotic fractures (with BMD) ranged from 2.5% to 90.8%. FRAX(®)-based hip fracture probabilities ranged from 0.1% to 90.3%. The incidence of clinical osteoporotic fractures (vertebral fractures excluded) and morphometric vertebral fractures increased with increasing baseline fracture probabilities. Treatment with strontium ranelate was associated with a 31% (95% CI = 20-39%) decrease in osteoporotic clinical fractures and a 40% decrease in vertebral fractures assessed by semiquantitative morphometry (95% CI = 31-48%) Hazard ratios for the effect of strontium ranelate on the fracture outcomes did not change significantly with increasing fracture probability.
Strontium ranelate significantly decreased the risk of osteoporotic clinical fractures, non vertebral fractures and morphometric vertebral fractures in women. Overall, the efficacy of strontium ranelate was not dependent of the level of fracture risk assessed by FRAX.
本研究旨在确定雷奈酸锶的疗效是否与基线骨折风险有关。雷奈酸锶治疗与所有临床骨质疏松性骨折（包括椎体骨折）的发生率显著降低 31%相关。雷奈酸锶对骨折结局的影响的风险比与骨折概率的增加无显著变化。
两项先前的研究表明，根据 FRAX®算法评估的骨折风险最高的人群中，干预的疗效可能更大。本研究的目的是确定雷奈酸锶的抗骨折疗效是否依赖于骨折风险水平。
将雷奈酸锶治疗绝经后骨质疏松症的两项 III 期研究（SOTI 和 TROPOS）的主要数据合并。使用 FRAX®工具（版本 2.0）计算各国的概率。主要观察变量包括所有临床骨质疏松性骨折（包括临床椎体骨折）。采用泊松回归法探索骨折概率与疗效之间的相互作用。
10 年主要骨质疏松性骨折（有 BMD）的概率范围为 2.5%至 90.8%。FRAX®-基于髋部骨折的概率范围为 0.1%至 90.3%。临床骨质疏松性骨折（不包括椎体骨折）和形态计量椎体骨折的发生率随基线骨折概率的增加而增加。雷奈酸锶治疗与骨质疏松性临床骨折发生率降低 31%（95%CI=20-39%）和形态计量学椎体骨折发生率降低 40%（95%CI=31-48%）相关。雷奈酸锶对骨折结局的影响的风险比与骨折概率的增加无显著变化。
雷奈酸锶显著降低了女性骨质疏松性临床骨折、非椎体骨折和形态计量学椎体骨折的风险。总体而言，雷奈酸锶的疗效与 FRAX 评估的骨折风险水平无关。
