RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
Recruiting · NCT06643780 · Interventional (participants receive a specific treatment) · Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
DenosumabZolendronic Acid
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed.
- The Chinese University of Hong Kong - Hong Kong, China