The relationship between bisphosphonate adherence and fracture: is it the behavior or the medication? Results from the placebo arm of the fracture intervention trial.
The relationship between bisphosphonate adherence and fracture: is it the behavior or the medication? Results from the placebo arm of the fracture intervention trial.
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DOI：
10.1002/jbmr.274
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发表时间：
2011-04
影响因子：
6.2
通讯作者：
Bauer, Douglas C.
中科院分区：
文献类型：
--
作者：
Curtis, Jeffrey R.;Delzell, Elizabeth;Chen, Lang;Black, Dennis;Ensrud, Kristine;Judd, Suzanne;Safford, Monika M.;Schwartz, Ann V.;Bauer, Douglas C.
药物依从性可能可以替代改善骨折等健康结果的因素。人们对这种潜在的“健康依从者”效应的大小知之甚少。我们评估了以下假设：在参加骨折干预试验 (FIT) 的女性中，安慰剂的依从性与骨质流失和骨折呈负相关。使用每日用药日记评估对安慰剂和阿仑膦酸钠的依从性。如果女性服用了 80% 或更多的研究药物，则她们被定义为具有高依从性。使用混合模型评估骨矿物质密度（BMD）的变化，比较安慰剂依从性高与低的女性。 Cox 比例风险模型分析了安慰剂依从性与各种类型骨折之间的关联。在 3169 名随机接受安慰剂的女性中，82% 的患者依从性较高。与安慰剂依从性较低的女性相比，依从性安慰剂治疗的女性的全髋骨丢失较低（-0.43%/年与-0.58%/年，p = .04）。在接受安慰剂治疗的女性中，有 46 例髋部骨折、110 例腕部骨折、77 例临床椎骨骨折和 492 例临床骨折。与安慰剂依从性较低的女性相比，安慰剂依从性较高的女性髋部骨折风险并未显着降低[调整后风险比 (HR) = 0.67，95% 置信区间 (CI) 0.30–1.45]。其他骨折未观察到这种趋势。药物依从性可能是一个代理因素，这些因素可以减少髋部骨折（但不能减少其他类型的骨折），而与药物本身的效果无关。旨在维持或改善骨密度和/或髋部骨折的干预措施的非随机研究可能需要将药物依从性视为混杂因素，以更好地估计真正的干预效果。 © 2011 美国骨与矿物质研究学会。
Medication compliance may be a surrogate for factors that improve health outcomes such as fractures. Little is known about the size of this potential “healthy adherer” effect. We evaluated the hypothesis that compliance with placebo is associated inversely with bone loss and fractures among women participating in the Fracture Intervention Trial (FIT). Compliance with placebo and alendronate was evaluated using daily medication diaries. Women were defined as having high compliance if they took 80% or more of dispensed study medication. Change in bone mineral density (BMD) was assessed using mixed models comparing women with high versus lower compliance with placebo. Cox proportional-hazards models analyzed the association between placebo compliance and various types of fractures. Among 3169 women randomized to placebo, 82% had high compliance. Compared with women with lower placebo compliance, bone loss at the total hip was lower in compliant placebo-treated women (−0.43%/year versus −0.58%/year, p = .04). Among placebo-treated women, there were 46 hip, 110 wrist, 77 clinical vertebral, and 492 total clinical fractures. Compared with women with lower placebo compliance, women with high placebo compliance had a nonsignificant reduced risk for hip fracture [adjusted hazard ratio (HR) = 0.67, 95% confidence interval (CI) 0.30–1.45]. This trend was not observed for other fractures. Medication compliance may be a proxy for factors that confers benefit on reducing hip fracture (but not other types of fractures) independent of the effect of the medication itself. Nonrandomized studies of interventions designed to maintain or improve bone density and/or hip fracture may need to consider medication compliance as a confounder to better estimate true intervention effects. © 2011 American Society for Bone and Mineral Research.
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