RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients
NCT ID: NCT07056478
Last Updated: 2025-07-09
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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NOT_YET_RECRUITING
PHASE3
130 participants
INTERVENTIONAL
2026-01-01
2030-01-01
Brief Summary
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Detailed Description
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1. To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of physical performance and quality of life.
2. To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of appendicular skeletal muscle mass and muscle strength.
3. To investigate the efficacy of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of falls, hospital re-admissions, re-fractures, and mortality.
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 (Prolia)
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
Zoledronic acide (Aclasta)
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Interventions
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Denosumab (Prolia)
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Zoledronic acide (Aclasta)
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 sarcopenia following AWGS guidelines - low appendicular skeletal muscle mass measured by dual-energy x-ray absorptiometry (Cutoff: Male \<7.0kg/m2, and female \<5.4kg/m2) AND low handgrip strength (Cutoff: Male \< 28kg, Female \<18 kg) OR low physical performance (6-metre walk, cutoff: \<1.0m/s or 5-time chair stand test \>=12s)
* Diagnosed with a hip fracture from low-energy mechanism (e.g., falling from standing height) requiring an operation
* Willing and able to comply with study protocol including follow-up evaluations.
Exclusion Criteria
* multiple fractures
* pathological fractures e.g., tumour, infection, etc.
* history of medication or disease affecting bone metabolism e.g., hypo/hyperthyroidism
* malignancy
* chairbound or bedbound (unable to perform assessments)
* serious cognitive problems e.g., severe dementia (unable to agree for consent) - renal impairment with glomerular filtration rate \<30 mL/min
* prior anti-osteoporotic medication e.g. bisphosphonates, denosumab, etc.
* active infection,
* severe malnutrition i.e. Mini Nutritional Assessment \< 17 points
* serious neurological or neuromuscular conditions e.g. Parkinson's disease
* uncontrolled chronic conditions e.g. poorly controlled diabetes mellitis
* not anaesthetically fit for operation or conservative management
65 Years
ALL
No
Sponsors
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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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Other Identifiers
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2023.401
Identifier Type: -
Identifier Source: org_study_id
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