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Recruiting NCT06643780

RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis

Phase IV Interventional Sarcopenia in Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Denosumab, Zolendronic Acid.
Who it may be relevant to
Registry conditions: Sarcopenia in Elderly. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 6-metre walk [Time frame: From enrollment to the end of treatment at 52 weeks]
  • 5-time chair stand test [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Appendicular skeletal muscle mass (ASM) [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Handgrip strength [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Quadriceps muscle strength [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Balancing ability [Time frame: From enrollment to the end of treatment at 52 weeks]
Secondary outcome measures (7)
  • Falls [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Fracture [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Quality of life Short Form-36 (SF-36) [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Physical activity scale for elderly (PASE) [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Food frequency questionnaire [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Hospital admissions [Time frame: From enrollment to the end of treatment at 52 weeks]
  • Mortality [Time frame: From enrollment to the end of treatment at 52 weeks]

Eligibility criteria

Inclusion criteria

  • Elderly males or females aged 65 years or older
  • diagnosed with osteosarcopenia (sarcopenia diagnosis based on AWGS 2019 guidelines - low appendicular skeletal muscle mass (ASM) by Dual-energy X-ray absorptiometry (DXA) (M:\<7.0kg/m2, F:\<5.4kg/m2) AND low handgrip strength (M:\<28kg, F:\<18kg) OR low physical performance (6-metre walk: \<1.0m/s or 5-time chair stand test ≥ 12 s); osteoporosis diagnosed based on World Health Organization (WHO) criteria with DXA scan T-score ≤ -2.5)
  • Willing and able to comply with study protocol including follow-up evaluations.

Exclusion criteria

  • history of recent fracture i.e., within 3 months
  • history of prior anti-osteoporotic drug
  • disease or medication affecting bone or muscle metabolism
  • Chairbound or bedbound
  • Unable to agree for consent
  • contraindication to drug i.e., Denosumab or Zoledronic Acid
  • Underlying malignancy or disease known to cause cachexia
  • severe renal impairment e.g., Creatinine Clearance (CrCl) \< 35ml/min
  • moderate to severe liver failure (Child-Pugh Class B or C).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Publications

  • Wong RMY, Wong PY, Liu C, Tang N, Wan RCW, Liu WH, Cui C, Zhang N, Kwok TCY, Law SW, Cheung WH. RANK-ligand inhibition to combat sarcopenia with underlying osteoporosis: a study protocol for a randomized, double-blind, double-dummy, active-controlled trial. Trials. 2025 Aug 4;26(1):269. doi: 10.1186/s13063-025-08976-7. PMID 40760465

Identifiers

NCT: NCT06643780 · 2022.555

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗