NCT06643780 RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
| NCT ID | NCT06643780 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong |
| Condition | Sarcopenia in Elderly |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-04-09 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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:\&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. 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06643780 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Sarcopenia in Elderly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06643780 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06643780 currently recruiting?
Yes, NCT06643780 is actively recruiting participants. Contact the research team at ronald.wong@cuhk.edu.hk for enrollment information.
Where is the NCT06643780 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT06643780 clinical trial?
NCT06643780 is sponsored by Prince of Wales Hospital, Shatin, Hong Kong. The trial plans to enroll 120 participants.