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Taking people in ChinaPhase 4

Tests denosumab against zoledronic acid for muscle loss with osteoporosis

Compares denosumab with zoledronic acid in older adults with muscle loss and osteoporosis.

Plain-language title generated from the registry record
Registry title: RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis

Key facts

Where
Hong Kong, ChinaSee the site
Phase
Phase 4

Where in China

  • The Chinese University of Hong KongHong Kong, ChinaTaking people

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  4. What happens if I want to stop?
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Trial details

Who runs it
Prince of Wales Hospital, Shatin, Hong Kong
Trial code
NCT06643780
Record updated
18 September 2026
Original description
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.Read full original descriptionShow less

RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis: A Randomized, Double-blind, Double-dummy, Active-Controlled 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.

Inclusion: 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: history of prior anti-osteoporotic drug; contraindication to drug i.e., Denosumab or Zoledronic Acid; history of recent fracture i.e., within 3 months; disease or medication affecting bone or muscle metabolism; Underlying malignancy or disease known to cause cachexia; moderate to severe liver failure (Child-Pugh Class B or C); severe renal impairment e.g., Creatinine Clearance (CrCl) \< 35ml/min; Chairbound or bedbound; Unable to agree for consent.

ClinicalTrials.gov NCT06643780