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
Prince of Wales Hospital, Shatin, Hong Kong
120 participants
Apr 9, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria9
- 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).
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Interventions
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06643780