Bisphosphonates for the Prevention of Fractures in Osteogenesis Imperfecta: Meta-Analysis of Placebo-Controlled Trials
Bisphosphonates for the Prevention of Fractures in Osteogenesis Imperfecta: Meta-Analysis of Placebo-Controlled Trials
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DOI：
10.1002/jbmr.2410
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发表时间：
2015-05-01
影响因子：
6.2
通讯作者：
Ralston, Stuart H.
中科院分区：
文献类型：
--
作者：
Hald, Jannie D.;Evangelou, Evangelos;Ralston, Stuart H.
双膦酸盐广泛用于治疗成骨不全 (OI) 患者，目的是降低骨折风险。尽管有强有力的证据表明双磷酸盐可以增加成骨不全症的骨矿物质密度，但对骨折发生的影响并不一致。本研究的目的是通过对以骨折为报告终点的随机对照试验进行荟萃分析，更好地了解双膦酸盐治疗对成骨不全患者骨折风险的影响。我们检索了 Medline、Embase 和 Cochrane 对照试验中心注册库，其中将双磷酸盐对成骨不全症骨折风险的影响与安慰剂进行了比较，并使用标准方法对这些研究进行了荟萃分析。使用 I-2 统计量评估异质性。确定了六项符合条件的研究，涉及 424 名受试者，并进行了 751 患者年的随访。双磷酸盐治疗并未显着降低发生骨折的患者比例（相对风险 [RR]=0.83 [95% 置信区间 0.69-1.01]，p=0.06），研究之间没有异质性 (I-2=0)。当考虑所有研究时，双磷酸盐治疗降低了骨折率（RR=0.71 [0.52-0.96]，p=0.02），但存在相当大的异质性（I-2=36%），一项研究解释了这一情况，其中安慰剂组中的少数患者经历了大量骨折。当排除本研究时，双磷酸盐对骨折率的影响并不显着（RR=0.79 [0.61-1.02]，p=0.07，I-2=0%）。我们的结论是，双磷酸盐对预防成骨不全症骨折的作用尚无定论。需要对骨折终点进行足够有力的试验，以进一步研究双磷酸盐在这种情况下的风险和益处。 (c) 2014 年美国骨与矿物质研究学会。
Bisphosphonates are widely used off-label in the treatment of patients with osteogenesis imperfecta (OI) with the intention of reducing the risk of fracture. Although there is strong evidence that bisphosphonates increase bone mineral density in osteogenesis imperfecta, the effects on fracture occurrence have been inconsistent. The aim of this study was to gain a better insight into the effects of bisphosphonate therapy on fracture risk in patients with osteogenesis imperfecta by conducting a meta-analysis of randomized controlled trials in which fractures were a reported endpoint. We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials in which the effects of bisphosphonates on fracture risk in osteogenesis imperfecta were compared with placebo and conducted a meta-analysis of these studies using standard methods. Heterogeneity was assessed using the I-2 statistic. Six eligible studies were identified involving 424 subjects with 751 patient-years of follow-up. The proportion of patients who experienced a fracture was not significantly reduced by bisphosphonate therapy (Relative Risk [RR]=0.83 [95% confidence interval 0.69-1.01], p=0.06) with no heterogeneity between studies (I-2=0). The fracture rate was reduced by bisphosphonate treatment when all studies were considered (RR=0.71 [0.52-0.96], p=0.02), but with considerable heterogeneity (I-2=36%) explained by one study where a small number of patients in the placebo group experienced a large number of fractures. When this study was excluded, the effects of bisphosphonates on fracture rate was not significant (RR=0.79 [0.61-1.02], p=0.07, I-2=0%). We conclude that the effects of bisphosphonates on fracture prevention in osteogenesis imperfecta are inconclusive. Adequately powered trials with a fracture endpoint are needed to further investigate the risks and benefits of bisphosphonates in this condition. (c) 2014 American Society for Bone and Mineral Research.