NCT06643780RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 15 Sept 2024
- Start date
- 9 Apr 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Diseases
- Osteoporosis
- NCT number
- NCT06643780
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 9 Apr 2024 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- history of prior anti-osteoporotic drug
- contraindication to drug i.e., Denosumab or Zoledronic Acid
Other illness
- history of recent fracture i.e., within 3 months
- disease or medication affecting bone or muscle metabolism
- Underlying malignancy or disease known to cause cachexia
- moderate to severe liver failure (Child-Pugh Class B or C).
Lab values
- severe renal impairment e.g., Creatinine Clearance (CrCl) \< 35ml/min
Other
- Chairbound or bedbound
- Unable to agree for consent
Who the study is looking for
- 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:\&lt;7.0kg/m2, F:\&lt;5.4kg/m2) AND low handgrip strength (M:\&lt;28kg, F:\&lt;18kg) OR low physical performance (6-metre walk: \&lt;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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.