A Phase 4 interventional study of Denosumab and Zolendronic Acid in Sarcopenia in Elderly, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Phase 4, Interventional, and Treatment
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:
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Drug: Denosumab
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
Drug: Zolendronic Acid
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
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 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 (%).
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
Plan to share: No
Started Apr 2024 (actual). Primary completion is estimated for Apr 2027, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Denosumab
Prince of Wales Hospital, Shatin, Hong Kong