Using denosumab to treat sarcopenia in elderly patients with osteoporosis
RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis: a Randomized, Double-blind, Double-dummy, Active-Controlled Trial
This study is testing if denosumab can help older adults with osteoporosis build muscle strength and improve their overall health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong Academic / other |
| Drugs / interventions | Denosumab |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06643780 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of denosumab, a RANK-ligand inhibitor, in treating sarcopenia among elderly patients who also have osteoporosis. It is a randomized, double-blind, double-dummy active controlled trial that will measure changes in appendicular skeletal muscle mass, handgrip strength, and physical performance. Additionally, the study will assess improvements in quality of life and reductions in falls, fractures, hospital admissions, and mortality rates in this population.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 and older diagnosed with osteosarcopenia and osteoporosis.
Not a fit: Patients who are chairbound or bedbound, or those with contraindications to denosumab or zoledronic acid, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve muscle mass and strength, enhancing the quality of life for elderly patients with sarcopenia and osteoporosis.
How similar studies have performed: Other studies have shown promise in using RANK-ligand inhibition for related conditions, but this specific approach in osteosarcopenic patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, China (Recruiting)
Study contacts
- Study coordinator: Ronald Man Yeung Wong
- Email: ronald.wong@cuhk.edu.hk
- Phone: 852 3505 1654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.