RANK-ligand inhibition to combat sarcopenia with underlying osteoporosis: a study protocol for a randomized, double-blind, double-dummy, active-controlled trial
Abstract
Background: Sarcopenia is an age-related disease characterized by gradual loss of muscle strength and muscle mass. Osteosarcopenia is the presence of osteopenia/osteoporosis and sarcopenia, which poses an increased risk of falls and fractures. Currently, there is no Food and Drug Administration (FDA) approved drug for treating sarcopenia. Previous studies showed that nuclear factor-κB ligand (RANKL) inhibition could reduce muscle atrophy and could be a therapeutic target for treating sarcopenia. Denosumab is an anti-osteoporotic drug with RANKL inhibition. This study aims to investigate the effects of denosumab to treat sarcopenia in patients with underlying osteoporosis.
Methods: This study is a randomized, double-blind, double-dummy, active-controlled trial for investigating the efficacy of denosumab in treating sarcopenia in patients with osteosarcopenia. Participants aged 65 years or above with osteosarcopenia will be recruited. Participants will be randomized into the denosumab group or the zoledronic acid group and will be followed up for 1 year. The primary outcomes are muscle strength, muscle mass measured by dual-energy x-ray absorptiometry (DXA) scan, and physical performance. The secondary outcomes are the clinical outcomes, including fall rate, fracture rate and mortality.
Discussion: This study will study the potential therapeutical effects of denosumab (RANKL inhibitor) on osteosarcopenia, which will be crucial given the aging population and expected increase…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Effectiveness of Bisphosphonates and Denosumab on Risk of Vertebral Fractures in Prostate Cancer Patients Under Androgen Deprivation Therapies: A Real-World Prospective Study
- Osteoporosis-related fractures after spinal cord injury: a retrospective study from Brazil
- Serum 25-hydroxyvitamin D, parathyroid hormone, and mortality in older men
- Lack of Association between Vitamin D Insufficiency and Cardiovascular or Fracture Risk: A UK Biobank Study
- Muscle strength and body composition are clinical indicators of osteoporosis
- Incidence of bone protection and associated fragility injuries in patients with proximal femur fractures
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.