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.