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| Name | Class |
|---|---|
| Chinese University of Hong Kong | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab group | Active Comparator | 60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly |
|
| Zolendronic acid group | Placebo Comparator | 5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | 60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | 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 | From enrollment to the end of treatment at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | To assess the occurrence of falls, patients are required to self-report via a fall calendar, which will be returned at 1-year | From enrollment to the end of treatment at 52 weeks |
| Fracture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronald Man Yeung Wong | Contact | 852 3505 1654 | ronald.wong@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Recruiting | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40760465 | Derived | Wong RMY, Wong PY, Liu C, Tang N, Wan RCW, Liu WH, Cui C, Zhang N, Kwok TCY, Law SW, Cheung WH. RANK-ligand inhibition to combat sarcopenia with underlying osteoporosis: a study protocol for a randomized, double-blind, double-dummy, active-controlled trial. Trials. 2025 Aug 4;26(1):269. doi: 10.1186/s13063-025-08976-7. |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Zolendronic Acid | Drug | 5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months |
|
| 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 (%). |
| 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) | 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 (%) | 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 (%) | 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) | From enrollment to the end of treatment at 52 weeks |
Assess occurrence of a fracture within a year of study period.
| 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. | 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 | 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. | 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. | From enrollment to the end of treatment at 52 weeks |
| Mortality | Mortality within 1-year of study period is documented. | From enrollment to the end of treatment at 52 weeks |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |