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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Denosumab (Prolia)
Drug60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Zoledronic acide (Aclasta)
Drug5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Denosumab groupActive comparator 1 intervention
Group B: Zolendronic acid groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sarcopenia and Quality of Life (SarQoL®)
Health-related questionnaire for sarcopenia which is composed of 55 items translated into 22 questions and organized into seven domains of quality of life including physical and mental health, locomotion, body composition, functionality, activities of daily living, leisure activities, and fears. The SarQoL involves an overall score, which is the sum of seven individual domain scores, with higher scores indicating better quality of life. During the scoring process, the overall and domain scores are rescaled such that their maximum possible values become 100.
Time frame
From enrolment to 24 months after the start of treatment2
Quadriceps muscle strength
Measured on affected limb with isometric dynamometer (Baseline, Genova, Italy). Subject will sit on a chair with both feet above ground, while raising the affected leg 45° forwards. The dynamometer is placed above the ankle and subject will push the leg forward with maximum force. Measurements are repeated three times and maximum value used for evaluation
Time frame
From enrolment to 24 months after the start of treatment3
Handgrip strength
Assessed by handgrip strength with spring-type hand dynamometer (JAMAR Hand Dynamometer 5030JO; Sammons Preston, Bolingbrook, IL). The maximum reading of 2 trials using the dominant hand in a maximum-effort isometric contraction is taken. Male \< 28kg, and female \<18kg are cut-off for low handgrip strength
Time frame
From enrolment to 24 months after the start of treatment4
Appendicular skeletal muscle mass (ASM)
Determined with Dual-energy X-ray absorptiometry (Horizon®, Hologic, USA). Total appendicular skeletal mass (ASM) is evaluated by segmented measurement of muscle mass at four limbs by operator-defined cutlines at specific anatomical landmarks. ASM is adjusted to square of height to calculate appendicular skeletal mass index (ASMI) (kg/m2). Cutoff of low ASMI is defined as Male \<7.0kg/m2, and female \<5.4kg/m2.
Time frame
From enrolment to 24 months after the start of treatmentSecondary outcomes
1
Falls
Patients self-report via fall calendar, which will be returned at each follow-up. Calendar reporting has been well proven to be reliable for fall studies
Time frame
From enrolment to 24 months after the start of treatment2
Hospital re-admissions
Documented from Clinical Management System (CMS) from Hospital Authority (public computerized system for all patients)
Time frame
From enrolment to 24 months after start of treatment3
Secondary fracture
Confirmed via X-ray/radiology report and Clinical Management System (CMS). Lateral X-ray of spine also taken during follow-up to detect the often clinically silent vertebral fracture. Vertebra is assessed by Genant classification as per our previously established protocol
Time frame
From enrolment to 24 months after start of treatment4
Mortality
Documented from the Clinical Management System (CMS) from Hospital Authority (public computerized system for all patients)
Time frame
From enrolment to 24 months after start of treatmentSponsors and contacts
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Source ClinicalTrials.gov
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