Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial.
Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial.
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DOI：
10.1001/jamainternmed.2015.0747
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发表时间：
2015-06
影响因子：
39
通讯作者：
Resnick NM
中科院分区：
文献类型：
--
作者：
Greenspan SL;Perera S;Ferchak MA;Nace DA;Resnick NM
85%的机构老人有骨质疏松症，骨折率比社区老人高8-9倍。然而，大多数患者未经治疗，被排除在关键骨质疏松症试验之外。确定唑来膦酸对体弱老年妇女的疗效和安全性。该研究于2007年12月至2012年3月进行，为期2年，随机，安慰剂对照，双盲研究。养老院和辅助生活设施。181名年龄≥65岁的骨质疏松症女性，包括认知障碍、行动不便和多病患者。一次5mg剂量唑来膦酸或安慰剂IV，每日补钙和维生素d。(1)12个月和24个月时髋关节和脊柱骨矿物质密度（BMD）和(2)不良事件。在年龄（平均85.4±0.6岁）、骨密度、功能或认知状态方面没有基线差异，但治疗组包括更多虚弱、跌倒史、糖尿病和使用抗惊厥药的受试者。87%的参与者在12个月和73%的参与者在24个月时可以获得BMD。治疗组骨密度变化更大（p<0.01）： 12个月和24个月时全髋分别差异3.2±0.7和3.9±0.7个百分点（平均±SE），脊柱分别差异1.8±0.7和3.6±0.7个百分点（p<0.01）；调整后的分析结果相似。治疗组和安慰剂组骨折发生率分别为20%和16% (OR=1.30; 95% CI= 0.61-2.78)；死亡率分别为16%和13% （OR=1.24; 95% CI= 0.54-2.86）。组间单次跌倒的比例无差异（28%比24%；OR=1.24; 95% CI= 0.64-2.42; p=0.52），但治疗组中多次跌倒的受试者较多（49%比35%；OR=1.83; 95% CI= 1.01-3.33; p=0.047）；当对基线虚弱进行调整时，这不再显著。在这组虚弱、骨质疏松的女性中，一剂唑来膦酸改善骨密度超过2年。治疗组骨折和死亡率无显著增加的临床意义有待进一步研究。由于尚不清楚这种疗法是否能降低该队列中骨折的风险，因此养老院实践的任何改变都必须等待更大规模的试验结果来评估骨折率。临床试验。政府标识符NCT00558012
85% of institutionalized elderly have osteoporosis, with fracture rates 8–9 fold higher than observed among community-dwelling elderly. Yet most are untreated and excluded from pivotal osteoporosis trials. Determine the efficacy and safety of zoledronic acid in frail elderly women. 2-year, randomized, placebo-controlled, double-blinded study conducted between December 2007 and March 2012. Nursing home and assisted living facilities. 181 women ≥ age 65 with osteoporosis including those with cognitive impairment, immobility, and multimorbidity. One 5 mg dose of zoledronic acid or placebo IV and daily calcium and vitamin D. (1) Hip and spine bone mineral density (BMD) at 12 and 24 months and (2) adverse events. There were no baseline differences in age (mean=85.4±0.6 years), BMD, or functional or cognitive status, but the treatment group included more subjects with frailty, falls history, diabetes, and anticonvulsant use. BMD was available for 87% of participants at 12 months and 73% at 24 months. BMD changes were greater in the treatment group (p< 0.01): 3.2 ± 0.7 and 3.9 ± 0.7 percentage point differences (mean ± SE) in the total hip at 12 and 24 months respectively, and 1.8 ± 0.7 and 3.6 ± 0.7 at the spine (p<0.01); adjusted analyses were similar. The treatment and placebo groups’ fracture rates were 20% and 16%, respectively (OR=1.30; 95% CI=0.61–2.78); mortality rates were 16% and 13% (OR=1.24; 95% CI=0.54–2.86). Groups did not differ in the proportion of single fallers (28% vs. 24%; OR=1.24; 95% CI=0.64–2.42; p=0.52) but more subjects in the treatment group had multiple falls (49% vs. 35%; OR=1.83; 95% CI=1.01–3.33; p=0.047); this was no longer significant when adjusted for baseline frailty. In this group of frail, osteoporotic women, one dose of zoledronic acid improved BMD over 2 years. The clinical importance of nonsignificant increases in fracture and mortality rates in the treatment group need further study. Since it is not known whether such therapy reduces the risk of fracture in this cohort, any change in nursing home practice must await results of larger trials powered to assess fracture rates. Clinical Trials. Gov Identifier NCT00558012