The Chinese University of Hong Kong
Hong Kong, China
Location status: Recruiting
NCT Number: NCT06643780
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 4
Hong Kong, China
Location status: Recruiting
Aims:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From enrollment to the end of treatment at 52 weeks
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 8 weeks
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 52 weeks
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
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
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
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 (%).
Time frame: From enrollment to the end of treatment at 52 weeks
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
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
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
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
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
Assess occurrence of a fracture within a year of study period.
Time frame: From enrollment to the end of treatment at 52 weeks
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
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
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
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 within 1-year of study period is documented.
Contact information is provided by the study sponsor or research team.
Prince of Wales Hospital, Shatin, Hong Kong
Other
RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis: a Randomized, Double-blind, Double-dummy, Active-Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07575958
Atrophy, Muscular Atrophy
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07291765
Sarcopenia in Elderly
Cologne, North Rhine-Westphalia, Germany
View Trial DetailsNCT07390552
Atrophy, Muscular Atrophy
Seongnam-si, Gyeonggi-do, South Korea
View Trial DetailsNCT06811324
Atrophy, Body Weight
San Antonio, Texas, United States
View Trial Details