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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Denosumab
Drug60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Zolendronic Acid
Drug5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Treatment groups
120 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
6-metre walk
The time taken to walk 6 metres without deceleration. Average result of 2 trials is recorded. Slow speed is defined as \<1.0m/s.
Time frame
From enrollment to the end of treatment at 52 weeks2
5-time chair stand test
The time to rise from a chair 5 times is recorded. The cut-off for is taken at \>=12 seconds.
Time frame
From enrollment to the end of treatment at 8 weeks3
Appendicular skeletal muscle mass (ASM)
Determined with Dual-energy X-ray absorptiometry (Horizon®, DXA system, Hologic, USA). Total ASM by DXA 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 ASMI (kg/m2). Low ASMI by DXA is \< 7 kg/m2 for men and 5.4 kg/m2 for women.
Time frame
From enrollment to the end of treatment at 52 weeks4
Handgrip strength
Assessed by spring-type hand dynamometer (JAMAR Hand Dynamometer 5030JO). Cut-off for men is \< 28kg, and female is \<18kg. Maximum reading of 3 trials using dominant hand in a maximum-effort isometric contraction
Time frame
From enrollment to the end of treatment at 52 weeksSecondary outcomes
1
Falls
To assess the occurrence of falls, patients are required to self-report via a fall calendar, which will be returned at 1-year
Time frame
From enrollment to the end of treatment at 52 weeks2
Fracture
Assess occurrence of a fracture within a year of study period.
Time frame
From enrollment to the end of treatment at 52 weeks3
Quality of life Short Form-36 (SF-36)
The highest score is 900, and the lowest score is 0. Highest score indicates a better quality of life.
Time frame
From enrollment to the end of treatment at 52 weeks4
Physical activity scale for elderly (PASE)
It assesses the types of activities typically chosen by older adults, ranging from 0 to 793, with higher scores indicating greater physical activity
Time frame
From enrollment to the end of treatment at 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Prince of Wales Hospital, Shatin, Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Source ClinicalTrials.gov