Effect of osteoporosis treatments on risk of non-vertebral fractures: review and meta-analysis of intention-to-treat studies
Effect of osteoporosis treatments on risk of non-vertebral fractures: review and meta-analysis of intention-to-treat studies
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DOI：
10.1007/s00198-005-1945-x
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发表时间：
2005-10-01
影响因子：
4
通讯作者：
Watts, NB
中科院分区：
文献类型：
--
作者：
Boonen, S;Laan, RF;Watts, NB
大多数骨质疏松症治疗已被证明在降低椎骨骨折风险方面有效，而预防非椎骨骨折的证据则不那么直接。关于治疗疗效的结论应主要基于意向治疗（ITT）人群的分析，而不是探索性亚组分析;然而，非椎骨抗骨折疗效主要通过事后亚组分析得出。本综述和荟萃分析旨在评估几种骨质疏松症治疗的非椎体抗骨折疗效，包括对ITT人群进行更严格的评估。非椎体抗骨折疗效数据（ITT分析的定义终点，并通过X线片证实）来自至少持续3年的随机、安慰剂对照、III期临床试验。对两种双膦酸盐（阿仑膦酸盐和利塞膦酸盐）进行荟萃分析。计算活性治疗与安慰剂相比的相对风险（RR）、95%置信区间（CI）和统计学显著性。11项临床试验符合审查标准，其中3项具有统计学意义（P
Most osteoporosis treatments have proven efficacy in reducing the risk of vertebral fractures, whereas evidence is less straightforward for prevention of non-vertebral fractures. Conclusions as to the efficacy of a treatment should be based primarily on analyses of the intention to treat (ITT) population rather than on exploratory subgroup analyses; however, non-vertebral anti-fracture efficacy has been largely derived by post-hoc subgroup analyses. This review and meta-analysis was performed to assess non-vertebral anti-fracture efficacy of several osteoporosis therapies, including a more stringent assessment of the ITT populations. Data on non-vertebral anti-fracture efficacy, a defined endpoint of the ITT analyses and confirmed by radiographs, were obtained from randomized, placebo-controlled, phase III clinical trials of at least 3-year duration. Meta-analyses were performed for the two bisphosphonates, alendronate and risedronate. Relative risks (RR), 95% confidence intervals (CI) and statistical significance for active treatment compared with placebo were calculated. Eleven clinical trials met the criteria for review, three of which showed statistically significant ( P