RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
Trial Parameters
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:\<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 impairmen