NCT06643780

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

Recruiting now Phase 4 Last updated 13 October 2024

What this trial tests

Phase 4 trial testing Denosumab in Sarcopenia in Elderly in 120 participants. Currently enrolling.

Timeline

9 April 2024

Primary endpoint
1 April 2027

1 October 2027

Quick facts

Lead sponsor	Prince of Wales Hospital, Shatin, Hong Kong
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	120
Start date	9 April 2024
Primary completion	1 April 2027
Estimated completion	1 October 2027
Sites	1 location across China

Drugs / interventions tested

• Denosumab (DENOSUMAB) — full drug profile →
• Zolendronic Acid — full drug profile →

Conditions studied

• Sarcopenia in Elderly — all drugs for Sarcopenia in Elderly →

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Who can join

65 and older, any sex, with Sarcopenia in Elderly. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 6-metre walk
  Time frame: From enrollment to the end of treatment at 52 weeks
  The time taken to walk 6 metres without deceleration. Average result of 2 trials is recorded. Slow speed is defined as \<1.0m/s.
• 5-time chair stand test
  Time frame: From enrollment to the end of treatment at 8 weeks
  The time to rise from a chair 5 times is recorded. The cut-off for is taken at \>=12 seconds.
• Appendicular skeletal muscle mass (ASM)
  Time frame: From enrollment to the end of treatment at 52 weeks
  Determined with Dual-energy X-ray absorptiometry (Horizon®, DXA system, Hologic, USA). Total ASM by DXA is evaluated by segmented measurement of muscle mass at four limbs by operator-defined cutlines at specific anatomical landmarks. ASM is adjusted to square of height to calculate ASMI (kg/m2). Low ASMI by DXA is \< 7 kg/m2 for men and 5.4 kg/m2 for women.
• Handgrip strength
  Time frame: From enrollment to the end of treatment at 52 weeks
  Assessed by spring-type hand dynamometer (JAMAR Hand Dynamometer 5030JO). Cut-off for men is \< 28kg, and female is \<18kg. Maximum reading of 3 trials using dominant hand in a maximum-effort isometric contraction
• Quadriceps muscle strength
  Time frame: From enrollment to the end of treatment at 52 weeks
  Measured on affected limb with isometric dynamometer (Baseline, Genova, Italy). Subject will sit on a chair with both feet above ground, while raising the affected leg 45° forwards. The dynamometer is placed above the ankle and the subject will push the leg forward with maximum force. Measurements will be repeated 3 times and maximum value will be used for evaluation
• Balancing ability
  Time frame: From enrollment to the end of treatment at 52 weeks
  The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different targets. Measured parameters of limits of stability test includes directional control (%).

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sarcopenia and Muscle Aging: Updated Insights into Molecular Mechanisms and Translational Therapeutics.
   Nguyen TT, Dao T, Nguyen HT, Park JH, et al · · 2026 · cited 1× · PMID 41674227 · DOI 10.3803/enm.2025.2656
2. RANK-ligand inhibition to combat sarcopenia with underlying osteoporosis: a study protocol for a randomized, double-blind, double-dummy, active-controlled trial.
   Wong RMY, Wong PY, Liu C, Tang N, et al · · 2025 · PMID 40760465 · DOI 10.1186/s13063-025-08976-7