RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients
ConditionSarcopenia in Elderly
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorPrince of Wales Hospital, Shatin, Hong Kong
About this trial
The objective of this study is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures.
Eligibility criteria
Qualifiers
Elderly aged 65 years or older
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.
Disqualifiers
open fracture
multiple fractures
pathological fractures e.g., tumour, infection, etc.
history of medication or disease affecting bone metabolism e.g., hypo/hyperthyroidism
Trial design
Treatments tested in this trial
- Denosumab (Prolia)
- Zoledronic acide (Aclasta)
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov