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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
The Chinese University of Hong Kong
Hong Kong, China
RECRUITING6-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 weeks
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 weeks
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 weeks
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 weeks
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 the subject will push the leg forward with maximum force. Measurements will be repeated 3 times and maximum value will be used for evaluation
Time frame: From enrollment to the end of treatment at 52 weeks
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different targets. Measured parameters of limits of stability test includes directional control (%).
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Time frame: From enrollment to the end of treatment at 52 weeks
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different targets. Measured parameters of limits of stability test includes movement velocity (degrees/s)
Time frame: From enrollment to the end of treatment at 52 weeks
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different targets. Measured parameters of limits of stability test includes endpoint excursion (%)
Time frame: From enrollment to the end of treatment at 52 weeks
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different targets. Measured parameters of limits of stability test includes maximum excursion (%)
Time frame: From enrollment to the end of treatment at 52 weeks
Balancing ability
The Basic Balance Master System (NeuroCom International Inc, USA) is used to measure static and dynamic ability of subjects to maintain center of balance. Subjects will stand barefoot on force plate and control location of their center-of-gravity by weight-shifting to eight different targets. Measured parameters of limits of stability test includes reaction time(s)
Time frame: From enrollment to the end of treatment at 52 weeks
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 weeks
Fracture
Assess occurrence of a fracture within a year of study period.
Time frame: From enrollment to the end of treatment at 52 weeks
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 weeks
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 weeks
Food frequency questionnaire
Daily and weekly intake of 280 food items will be performed using a validated food frequency questionnaire developed in a local population survey. Mean nutrient quantitation and energy intake per day will be calculated referring to food composition tables derived from the Chinese Medical Sciences Institute and Centre for Food Safety in Hong Kong.
Time frame: From enrollment to the end of treatment at 52 weeks
Hospital admissions
Number and cause of emergency hospital admission within 1 year of study period are documented.
Time frame: From enrollment to the end of treatment at 52 weeks
Mortality
Mortality within 1-year of study period is documented.
Time frame: From enrollment to the end of treatment at 52 weeks