Sarcopenia in ElderlyPhase 4NCT06643780
RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis
A Phase 4 study testing Denosumab and Zolendronic Acid in people with Sarcopenia in Elderly, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- Denosumab and Zolendronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2024to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Unable to agree for consent
- contraindication to drug i.e., Denosumab or Zoledronic Acid
Show all 9Show fewer
- Underlying malignancy or disease known to cause cachexia
- severe renal impairment e.g., Creatinine Clearance (CrCl) \< 35ml/min
- moderate to severe liver failure (Child-Pugh Class B or C).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Ronald Man Yeung Wong, 852 3505 1654, ronald.wong@cuhk.edu.hk
About this study
Official title: RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis: A Randomized, Double-blind, Double-dummy, Active-Controlled 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.
Read the detailed description
Aims:
- 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.
- To assess whether RANKL-inhibition improves quality of life, and decreases falls, fractures, hospital admissions and mortality in osteosarcopenic patients.
- Conditions
- Sarcopenia in Elderly
- Being tested
- Denosumab, Zolendronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Zolendronic AcidDrug
5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months
| Study group | Role | What they receive |
|---|---|---|
| Denosumab group | Active comparator | 60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly Receives: Drug: Denosumab |
| Zolendronic acid group | Placebo comparator | 5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months Receives: Drug: Zolendronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-metre walk
The time taken to walk 6 metres without deceleration. Average result of 2 trials is recorded. Slow speed is defined as \&lt;1.0m/s.
Measured: 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 \&gt;=12 seconds.
Measured: 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 \&lt; 7 kg/m2 for men and 5.4 kg/m2 for women.
Measured: 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 \&lt; 28kg, and female is \&lt;18kg. Maximum reading of 3 trials using dominant hand in a maximum-effort isometric contraction
Measured: 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
Measured: 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 (%).
Measured: 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)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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)
Measured: From enrollment to the end of treatment at 52 weeks
Secondary outcomes (7)
Falls
To assess the occurrence of falls, patients are required to self-report via a fall calendar, which will be returned at 1-year
Measured: From enrollment to the end of treatment at 52 weeks
Fracture
Assess occurrence of a fracture within a year of study period.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 52 weeks
Mortality
Mortality within 1-year of study period is documented.
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start9 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Ronald Man Yeung WONG, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643780
- Sponsor's protocol ID
- 2022.555
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40760465
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis: A Randomized, Double-blind, Double-dummy, Active-Controlled Trial
- ClinicalTrials.gov ID
- NCT06643780
- Acronym / sponsor ID
- 2022.555
- Conditions
- Sarcopenia in Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aims:
- 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.
- To assess whether RANKL-inhibition improves quality of life, and decreases falls, fractures, hospital admissions and mortality in osteosarcopenic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab group | Active comparator | Drug: Denosumab60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly |
| Zolendronic acid group | Placebo comparator | Drug: Zolendronic Acid5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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:\&lt;7.0kg/m2, F:\&lt;5.4kg/m2) AND low handgrip strength (M:\&lt;28kg, F:\&lt;18kg) OR low physical performance (6-metre walk: \&lt;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.
Key exclusion criteria (9 listed)
- 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
- Unable to agree for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denosumab60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly | Drug | Denosumab group |
| Zolendronic Acid5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months | Drug | Zolendronic acid group |
Primary outcome
6-metre walk
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 \&lt;1.0m/s.
5-time chair stand test
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 \&gt;=12 seconds.
Appendicular skeletal muscle mass (ASM)
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 \&lt; 7 kg/m2 for men and 5.4 kg/m2 for women.
Handgrip strength
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 \&lt; 28kg, and female is \&lt;18kg. Maximum reading of 3 trials using dominant hand in a maximum-effort isometric contraction
Quadriceps muscle strength
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
Balancing ability
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 (%).
Balancing ability
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)
Balancing ability
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 (%)
Balancing ability
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 (%)
Balancing ability
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)
7 secondary outcomes
Falls
Time frame: From enrollment to the end of treatment at 52 weeks
Fracture
Time frame: From enrollment to the end of treatment at 52 weeks
Quality of life Short Form-36 (SF-36)
Time frame: From enrollment to the end of treatment at 52 weeks
Physical activity scale for elderly (PASE)
Time frame: From enrollment to the end of treatment at 52 weeks
Food frequency questionnaire
Time frame: From enrollment to the end of treatment at 52 weeks
Hospital admissions
Time frame: From enrollment to the end of treatment at 52 weeks
Mortality
Time frame: From enrollment to the end of treatment at 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 40760465Wong 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.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia in Elderly
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
RecruitingObservational study
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Colorectal Cancer, Sarcopenia
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab and Zolendronic Acid in people with Sarcopenia in Elderly, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronald Man Yeung Wong (852 3505 1654, ronald.wong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-metre walk (time frame: From enrollment to the end of treatment at 52 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06643780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.