RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
NCT ID: NCT06643780
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2024-04-09
2027-10-31
Brief Summary
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Detailed Description
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1. 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.
2. To assess whether RANKL-inhibition improves quality of life, and decreases falls, fractures, hospital admissions and mortality in osteosarcopenic patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Denosumab group
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Denosumab
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Zolendronic acid group
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Zolendronic Acid
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Interventions
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Denosumab
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Zolendronic Acid
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Eligibility Criteria
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Inclusion Criteria
* 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 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).
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Prince of Wales Hospital, Shatin, Hong Kong
OTHER
Responsible Party
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Ronald Man Yeung WONG
Clinical Associate Professor
Locations
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The Chinese University of Hong Kong
Hong Kong, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Wong RMY, Wong PY, Liu C, Tang N, Wan RCW, Liu WH, Cui C, Zhang N, Kwok TCY, Law SW, Cheung WH. RANK-ligand inhibition to combat sarcopenia with underlying osteoporosis: a study protocol for a randomized, double-blind, double-dummy, active-controlled trial. Trials. 2025 Aug 4;26(1):269. doi: 10.1186/s13063-025-08976-7.
Other Identifiers
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2022.555
Identifier Type: -
Identifier Source: org_study_id
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