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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

Denosumab

60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly

DRUG

Zolendronic Acid

5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months

Locations (1)

The Chinese University of Hong Kong
Hong Kong, China