RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis
ConditionSarcopenia in Elderly
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorPrince of Wales Hospital, Shatin, Hong Kong
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Denosumab
- Zolendronic Acid
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Prince of Wales Hospital, Shatin, Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Source ClinicalTrials.gov