Once-Yearly Zoledronic Acid and Days of Disability, Bed Rest, and Back Pain: Randomized, Controlled HORIZON Pivotal Fracture Trial
Once-Yearly Zoledronic Acid and Days of Disability, Bed Rest, and Back Pain: Randomized, Controlled HORIZON Pivotal Fracture Trial
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DOI：
10.1002/jbmr.292
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发表时间：
2011-05-01
影响因子：
6.2
通讯作者：
Reid, Ian R.
中科院分区：
文献类型：
--
作者：
Cauley, Jane A.;Black, Dennis;Reid, Ian R.
本研究的目的是确定唑来膦酸一年一次对绝经后骨质疏松症女性背痛或骨折所致背痛天数和残疾天数（即活动受限和卧床休息）的影响。这是一项在27个国家的240个临床中心进行的多中心、随机、双盲、安慰剂对照试验。参与者包括7736名绝经后骨质疏松症妇女。患者在基线、12个月和24个月时随机接受单次15分钟静脉输注唑来膦酸（5 mg）或安慰剂。主要的结果指标是自我报告的背痛天数和由于背痛或骨折而限制活动和卧床休息的天数，在3年的时间内每3个月进行一次评估。我们的研究结果表明，尽管两个随机分组的背痛发生率都很高，但在整个试验过程中，与安慰剂组相比，随机分配到唑来膦酸组的妇女平均背痛天数减少了18天（p = 0.0092）。与安慰剂组相比，随机分配到唑来膦酸组的妇女的背痛导致活动受限天数减少11天（p = 0.0017）。在考克斯比例风险模型中，随机分配至唑来膦酸组的女性发生7天或7天以上背痛[相对风险（RR）= 0.94，95%置信区间（CI）0.90-0.99]或因背痛而活动受限（RR = 0.94，95% CI 0.87-1.00）的可能性降低约6%。随机分配至唑来膦酸组的女性因骨折而卧床休息7天或以上（RR = 0.58，95% CI 0.47-0.72）和因骨折而活动受限7天或以上（RR = 0.67，95% CI 0.58-0.78）的可能性显著降低。唑来膦酸对背痛的缓解与骨折无关。我们的结论是，在绝经后骨质疏松症的妇女，每年一次注射唑来膦酸超过3年的时间显着减少了患者报告背痛，活动受限，由于背痛，活动受限和卧床休息，由于骨折的天数。(C)2011年美国骨与矿物质研究学会。
The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were self-reported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p = .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p = .0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR) = 0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR = 0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR = 0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR = 0.67, 95% CI 0.58-0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the number of days that patients reported back pain, limited activity owing to back pain, and limited activity and bed rest owing to a fracture. (C) 2011 American Society for Bone and Mineral Research.