Relationship of changes in total hip bone mineral density to vertebral and nonvertebral fracture risk in women with postmenopausal osteoporosis treated with once-yearly zoledronic acid 5 mg: The HORIZON-Pivotal Fracture Trial (PFT)
Relationship of changes in total hip bone mineral density to vertebral and nonvertebral fracture risk in women with postmenopausal osteoporosis treated with once-yearly zoledronic acid 5 mg: The HORIZON-Pivotal Fracture Trial (PFT)
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DOI：
10.1002/jbmr.1644
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发表时间：
2012-08-01
影响因子：
6.2
通讯作者：
Eastell, Richard
中科院分区：
文献类型：
--
作者：
Jacques, Richard M.;Boonen, Steven;Eastell, Richard
骨矿物质密度（BMD）变化的测量被认为是降低骨折风险的治疗效果的弱预测指标。在这项研究中，我们报告了一种替代的逐年方法，用于估计BMD解释的治疗效果，其中我们研究了骨折风险与BMD最近变化之间的关系。我们研究了7736名绝经后妇女（年龄65 - 89岁），她们参加了唑来膦酸一年一次治疗骨折的健康结局和降低发病率试验（HORIZON-PFT），并被随机分配到唑来膦酸静脉给药组或安慰剂组。使用替代的逐年方法和观察3年内变化的标准方法估计了全髋关节BMD变化解释的治疗效果百分比。我们还研究了1132名妇女的一个子集，在基线和12个月时测量了1型前胶原氨基末端前肽（PINP），以估计PINP变化解释的治疗效果百分比。无论使用何种方法，全髋关节BMD的变化解释了唑来膦酸在降低新发椎体骨折风险方面的大部分作用（40%; 95%CI，30%-54%; 3年分析）。非椎骨骨折的治疗效果在逐年分析中没有统计学意义，但BMD的3年变化解释了61%（95% CI，24%至156%）的治疗效果。PINP的变化解释了唑来膦酸降低新发椎体骨折风险的58%（95% CI，15%-222%）作用。我们的结论是，我们的估计百分比的治疗效果解释可能高于以往的研究，因为高依从性唑来膦酸（由于其每年一次静脉注射给药）。以前的研究可能低估了BMD变化与治疗对骨折风险影响之间的关系。(C)2012年美国骨与矿物质研究学会。
Measurements of change in bone mineral density (BMD) are thought to be weak predictors of treatment effect on the reduction of fracture risk. In this study we report an alternative year-on-year approach for the estimation of treatment effect explained by BMD in which we examine the relationship between fracture risk and the most recent change in BMD. We studied 7736 postmenopausal women (ages 65 to 89 years) who were participants in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once YearlyPivotal Fracture Trial (HORIZON-PFT) and were randomized to either intravenous administration of zoledronic acid or placebo. The percentage of treatment effect explained by change in total hip BMD was estimated using the alternative year-on-year approach and the standard approach of looking at change over 3 years. We also studied a subset of 1132 women in whom procollagen type 1 amino-terminal propeptide (PINP) was measured at baseline and 12 months, to estimate the percentage of treatment effect explained by change in PINP. Regardless of the method used, the change in total hip BMD explained a large percentage of the effect of zoledronic acid in reducing new vertebral fracture risk (40%; 95% CI, 30% to 54%; for the 3-year analysis). The treatment effects for nonvertebral fracture were not statistically significant for the year-on-year analysis but 3-year change in BMD explained 61% (95% CI, 24% to 156%) of treatment effect. Change in PINP explained 58% (95% CI, 15% to 222%) of the effect of zoledronic acid in reducing new vertebral fracture risk. We conclude that our estimates of the percentage of treatment effect explained may be higher than in previous studies because of high compliance with zoledronic acid (due to its once-yearly intravenous administration). Previous studies may have underestimated the relationship between BMD change and the effect of treatment on fracture risk. (C) 2012 American Society for Bone and Mineral Research.