摘要
【Abstract】【Background】In long‐term care (LTC), the incidence of hip or vertebral fractures are eight times that in the community. Despite the wide availability of osteoporosis therapy, LTC residents are omitted from pivotal trials and not treated. Denosumab is a relatively new, monoclonal antibody therapy for osteoporosis treatment. Via a randomized trial, we sought to determine the safety and efficacy of denosumab in LTC residents.【Methods】We conducted a 2‐year, double‐blind, placebo‐controlled, randomized clinical trial in 201 osteoporotic men and women aged ≥ 65 years, living in LTC communities. Participants with multimorbidity, dysmobility, and cognitive impairment were not excluded. The intervention was denosumab 60 mg subcutaneous every 6 months or placebo. Our primary outcome measures were hip and spine bone mineral density (BMD) improvement at 24 months. Secondary outcomes included BMD at other skeletal sites, function, and safety.【Results】We included 123 women and 78 men with a mean ± standard error age of 81.5 ± 0.6. Overall, 83% and 71% completed 12 and 24 months, respectively. Compared with placebo, the women receiving denosumab had a greater 24‐month percent increase in spine (7.41 ± 0.93 vs. 2.15 + 0.56; p = 0.014), and total hip BMD (4.62 ± 0.62 vs. −0.19 ± 0.79; p = 0.007); and men in spine (7.91 ± 0.96 vs. 1.12 ± 1.13; p = 0.002) and total hip (3.74 ± 0.55 vs. 0.48 ± 0.74; p = 0.018). There were no significant differences in safety metrics.【Conclusions】Denosumab was a safe and effective therapy for improving BMD in osteoporotic older men and women with multiple comorbidities in LTC.
摘要译文
【摘要】【背景】在长期护理（LTC）中，髋关节或椎骨骨折的发生率是社区中的八倍。尽管骨质疏松疗法的可用性广泛，但LTC居民仍被关键试验省略，但未治疗。Denosumab是一种相对较新的单克隆抗体治疗，用于骨质疏松症治疗。通过一项随机试验，我们试图确定Denosumab在LTC居民中的安全性和疗效。【方法】我们在2011年≥65岁的201个骨质疏松性男性和妇女中进行了2年，双盲，安慰剂对照，随机临床试验，居住在LTC社区。没有排除具有多个多发病，衰退和认知障碍的参与者。干预措施是每6个月或安慰剂每6个月皮下denosumab。我们的主要结局指标是24个月时髋关节和脊柱骨矿物质密度（BMD）改善。次要结果包括其他骨骼部位的BMD，功能和安全性。总体而言，分别为83％和71％的人完成了12和24个月。与安慰剂相比，接受denosumab的妇女的脊柱增加了24个月的增长百分比（7.41±0.93 vs. 2.15+0.56; p = 0.014），总髋关节BMD（4.62±0.62 vs. -0.19±0.79; p = 0.007）;脊柱中的男性（7.91±0.96 vs. 1.12±1.13; p = 0.002）和总臀部（3.74±0.55 vs. 0.48±0.74; p = 0.018）。安全指标没有显着差异。【结论】denosumab是一种安全有效的疗法，可改善在LTC中具有多种合并症的骨质疏松型老年男性和女性的BMD。
Susan L. Greenspan [1];Subashan Perera [2];Nami Safai Haeri (0000-0002-5115-5980) [3];David A. Nace (0000-0002-3742-6991) [4];Neil M. Resnick [5];. Denosumab for osteoporosis in older adults in long‐term care: A randomized trial[J]. Journal of the American Geriatrics Society, 2025,73(2): 445-457