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Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial.

ABSTRACT: Eighty-five percent of institutionalized elderly people have osteoporosis and bone fracture rates 8 to 9 times higher than rates observed among community-dwelling elderly people. Nevertheless, most of these persons are left untreated and are excluded from pivotal osteoporosis trials.To determine the efficacy and safety of zoledronic acid to treat osteoporosis in frail elderly women in long-term care facilities.We conducted a 2-year, randomized, placebo-controlled, double-blinded study from December 2007 through March 2012. Included were 181 women 65 or older with osteoporosis, including those with cognitive impairment, immobility, and multimorbidity, who were living in nursing homes and assisted-living facilities.One 5-mg dose of zoledronic acid or placebo intravenously and daily calcium and vitamin D supplementation.Hip and spine bone mineral density (BMD) at 12 and 24 months and adverse events.There were no baseline differences in mean (SE) age (85.4 [0.6] years), BMD, or functional or cognitive status, but the treatment group included more participants with frailty, falls history, diabetes, and anticonvulsant medication use. Values for BMD were available for 87% of participants at 12 months and 73% at 24 months. Mean (SE) BMD changes were greater in the treatment group: 3.2 (0.7) and 3.9 (0.7) percentage-point differences in the total hip at 12 and 24 months, respectively (P?

SUBMITTER: Greenspan SL

PROVIDER: S-EPMC4843134 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial.

Greenspan Susan L SL Perera Subashan S Ferchak Mary Anne MA Nace David A DA Resnick Neil M NM

JAMA internal medicine 20150601 6

<h4>Importance</h4>Eighty-five percent of institutionalized elderly people have osteoporosis and bone fracture rates 8 to 9 times higher than rates observed among community-dwelling elderly people. Nevertheless, most of these persons are left untreated and are excluded from pivotal osteoporosis trials.<h4>Objective</h4>To determine the efficacy and safety of zoledronic acid to treat osteoporosis in frail elderly women in long-term care facilities.<h4>Design, setting, and participants</h4>We cond ...[more]

PMID: 25867538

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Project description:Increased understanding of the Wnt signaling pathway has led to the development of romosozumab, one of the most potent osteoanabolic agents to date for osteoporosis treatment. Romosozumab is a monoclonal antibody that inhibits sclerostin, a natural inhibitor of the Wnt signaling pathway. Romosozumab, by inhibiting sclerostin activates the Wnt signaling pathway, leading to increased bone formation and decreased bone resorption. The pivotal ARCH and FRAME studies established romosozumab's fracture reduction efficacy. Romosozumab was superior to alendronate in fracture reduction and bone mineral density gain in the ARCH study. Romosozumab treatment should be followed sequentially with a potent antiresorptive agent. The antifracture efficacy gained from romosozumab is maintained or improved after transitioning to an antiresorptive agent. As one of the most potent osteoanabolic agents, the introduction of romosozumab has significantly increased our ability to treat osteoporosis. Studies have provided important information on using romosozumab with other osteoporosis medications to optimize osteoporosis treatment. Romosozumab used before antiresorptive medications is associated with more significant bone mineral density increases than when an antiresorptive agent is used before romosozumab. Romosozumab is recommended for osteoporosis treatment in patients at very high risk for fracture with low cardiovascular risk. Romosozumab is generally well tolerated, with 4%-5% of patients having injection site reactions. The ARCH trial showed a higher risk of cardiovascular events in patients receiving romosozumab. Romosozumab carries a black box warning that romosozumab should not be initiated in patients with myocardial infarction or stroke in the preceding year. However, the information on romosozumab and increased cardiovascular risk is conflicting. The risk of cardiovascular disease with romosozumab is unclear. While romosozumab has demonstrated significant osteoanabolic effect and antifracture efficacy and will benefit high fracture risk patients, further studies are needed to investigate the cardiovascular safety of romosozumab.

Dataset Information

Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial.

Publications

Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial.

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