Overview
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.
Description
- Aims
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- To assess whether receptor activator of nuclear factor-kB ligand (RANKL)-inhibition can treat sarcopenia in osteosarcopenic patients, in terms of appendicular skeletal muscle mass (ASM), handgrip strength, and physical performance.
- To assess whether RANKL-inhibition improves quality of life, and decreases falls, fractures, hospital admissions and mortality in osteosarcopenic patients.
Eligibility
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).