Clinical trial NCT06643780: RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
Official title: RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis: a Randomized, Double-blind, Double-dummy, Active-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sarcopenia in Elderly
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2024-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Aims:

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.

Eligibility criteria: 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:\&amp;lt;7.0kg/m2, F:\&amp;lt;5.4kg/m2) AND low handgrip strength (M:\&amp;lt;28kg, F:\&amp;lt;18kg) OR low physical performance (6-metre walk: \&amp;lt;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) \&lt; 35ml/min
* moderate to severe liver failure (Child-Pugh Class B or C).

Primary outcomes:
measure: 6-metre walk
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: 5-time chair stand test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Appendicular skeletal muscle mass (ASM)
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Handgrip strength
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Quadriceps muscle strength
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Balancing ability
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Balancing ability
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Balancing ability
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Balancing ability
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Balancing ability
timeFrame: From enrollment to the end of treatment at 52 weeks
Secondary outcomes:
measure: Falls
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Fracture
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Quality of life Short Form-36 (SF-36)
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Physical activity scale for elderly (PASE)
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Food frequency questionnaire
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Hospital admissions
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Mortality
timeFrame: From enrollment to the end of treatment at 52 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
Study officials:
References: