Zoledronic acid and clinical fractures and mortality after hip fracture
Zoledronic acid and clinical fractures and mortality after hip fracture
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DOI：
10.1056/nejmoa074941
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发表时间：
2007-11-01
影响因子：
158.5
通讯作者：
Boonen, Steven
中科院分区：
文献类型：
--
作者：
Lyles, Kenneth W.;Colon-Emeric, Cathleen S.;Boonen, Steven
背景资料：死亡率增加后，髋部骨折，和战略，改善outcomes are needed.Methods：在这个随机，双盲，安慰剂对照试验，1065例患者被分配到每年静脉注射唑来膦酸（剂量为5毫克），和1062例患者被分配到接受安慰剂。在髋部骨折手术修复后90天内首次进行输注。所有患者（平均年龄74.5岁）均接受维生素D和钙补充治疗。中位随访时间为1.9年。结果：唑来膦酸组和安慰剂组新发骨折的发生率分别为8.6%和13.9%，唑来膦酸组的发生率降低了35%（P=0.001）;新发临床椎体骨折的发生率分别为1.7%和3.8%新发非椎体骨折发生率分别为7.6%和10.7%（P=0.03）。在安全性分析中，唑来膦酸组1054名患者中有101名（9.6%）死亡，安慰剂组1057名患者中有141名（13.3%）死亡，唑来膦酸组因任何原因死亡的人数减少了28%（P=0.01）。接受唑来膦酸治疗的患者最常见的不良事件是发热、肌痛和骨骼和肌肉骨骼疼痛。未报告颌骨骨坏死病例，也未观察到对骨折愈合的不良影响。肾脏和心血管不良事件，包括心房颤动和中风的发生率，在两个groups.Conclusions：唑来膦酸在修复后90天内每年输注低创伤髋部骨折与减少新的临床骨折的发生率和提高生存率。（ClinicalTrials.gov编号，NCT 00046254.）。
Background: Mortality is increased after a hip fracture, and strategies that improve outcomes are needed.Methods: In this randomized, double-blind, placebo-controlled trial, 1065 patients were assigned to receive yearly intravenous zoledronic acid (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgical repair of a hip fracture. All patients (mean age, 74.5 years) received supplemental vitamin D and calcium. The median follow-up was 1.9 years. The primary end point was a new clinical fracture.Results: The rates of any new clinical fracture were 8.6% in the zoledronic acid group and 13.9% in the placebo group, a 35% risk reduction with zoledronic acid (P=0.001); the respective rates of a new clinical vertebral fracture were 1.7% and 3.8% (P=0.02), and the respective rates of new nonvertebral fractures were 7.6% and 10.7% (P=0.03). In the safety analysis, 101 of 1054 patients in the zoledronic acid group (9.6%) and 141 of 1057 patients in the placebo group (13.3%) died, a reduction of 28% in deaths from any cause in the zoledronic acid group (P=0.01). The most frequent adverse events in patients receiving zoledronic acid were pyrexia, myalgia, and bone and musculoskeletal pain. No cases of osteonecrosis of the jaw were reported, and no adverse effects on the healing of fractures were noted. The rates of renal and cardiovascular adverse events, including atrial fibrillation and stroke, were similar in the two groups.Conclusions: An annual infusion of zoledronic acid within 90 days after repair of a low-trauma hip fracture was associated with a reduction in the rate of new clinical fractures and with improved survival. (ClinicalTrials.gov number, NCT00046254.).