NCT07056478

RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients

RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients: A Pragmatic, Randomized Double-blind, Active-Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (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 is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures.

Detailed description

Objectives 1. To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of physical performance and quality of life. 2. To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of appendicular skeletal muscle mass and muscle strength. 3. To investigate the efficacy of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of falls, hospital re-admissions, re-fractures, and mortality.

Conditions

• Sarcopenia in Elderly

Interventions

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

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: China