NCT06643780

RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis

RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis: a Randomized, Double-blind, Double-dummy, Active-Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to conduct a randomized, double-blind, double-dummy active controlled trial to determine the efficacy of denosumab in treating sarcopenia with underlying osteoporosis.

Detailed description

Aims: 1. To assess whether receptor activator of nuclear factor-kB ligand (RANKL)-inhibition can treat sarcopenia in osteosarcopenic patients, in terms of appendicular skeletal muscle mass (ASM), handgrip strength, and physical performance. 2. To assess whether RANKL-inhibition improves quality of life, and decreases falls, fractures, hospital admissions and mortality in osteosarcopenic patients.

Conditions

• Sarcopenia in Elderly

Interventions

Type	Name	Description
DRUG	Denosumab	60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
DRUG	Zolendronic Acid	5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months

Timeline

• Start date: 2024-04-09
• Primary completion: 2027-04-01
• Completion: 2027-10-01
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: China