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Randomized Controlled Trial
. 2025 Sep:198:117552.
doi: 10.1016/j.bone.2025.117552. Epub 2025 Jun 1.

Impact of denosumab on muscle health in older adults in long-term care

Affiliations
Randomized Controlled Trial

Impact of denosumab on muscle health in older adults in long-term care

Nami Safai Haeri et al. Bone. 2025 Sep.

Abstract

Background: Osteosarcopenia, a condition characterized by the simultaneous presence of osteoporosis and sarcopenia, is a common geriatric syndrome associated with increased risk of falls and fracture. While there are multiple medications available for the management of osteoporosis, there are currently no approved pharmacological treatments for sarcopenia.

Methods: In this secondary analysis of a 2-year, double-blind, placebo-controlled, randomized trial involving 201 men and women with osteoporosis aged ≥65 years who were residents of long-term care communities (LTCCs), we examined the impact of denosumab on various indices of muscle health. Study participants received either denosumab 60 mg every 6 months or a matching placebo. We measured appendicular lean mass (ALM/Height2), lower extremity lean mass (LELM), grip strength, chair stand test performance, gait speed, Short Physical Performance Battery (SPPB), and total hip and spine bone density at baseline and at 6, 12, and 24 months.

Results: Our study involved 78 men and 123 women, with a mean age of 81.5 years. There were no statistically significant differences between the denosumab and placebo groups in terms of changes in appendicular lean mass adjusted for ALM/Height2, LELM, chair stand performance, SPPB scores, or gait speed (all p > 0.05). However, in women, the chair stand test and grip strength showed non-significant greater improvements with denosumab at 18 and 24 months, suggesting a potential positive effect.

Conclusions: We did not find confirmatory evidence that denosumab impacts muscle health in older adults residing in LTCCs, despite its clear advantages for improving bone density. We observed non-significant improvements in grip strength and chair stand test performance in women, which warrant further investigation.

Mini abstract: Our study found that in older adults in LTCCs, denosumab did not significantly enhance muscle health indices.

Keywords: Denosumab; Muscle function; Muscle mass; Muscle strength; Osteosarcopenia; Sarcopenia.

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Conflict of interest statement

Declaration of competing interest Drs. Safai Haeri, Perera, and Greenspan report no conflicts of interest in the subject matter or materials discussed in this manuscript. Drs. Perera and Greenspan are investigators of other NIH-funded trials where study medication is provided by Amgen. The denosumab and matching placebo were provided by Amgen.

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