Sarcopenia in ElderlyPhase 3NCT07056478
RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients
A Phase 3 study testing Denosumab (Prolia) and Zoledronic acide (Aclasta) 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 is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures. 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 (Prolia) and Zoledronic acide (Aclasta)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 1 Jan 2030
- Phase
- Phase 3
- 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 aged 65 years or older
- Diagnosed with sarcopenia following AWGS guidelines - low appendicular skeletal muscle mass measured by dual-energy x-ray absorptiometry (Cutoff: Male <7.0kg/m2, and female <5.4kg/m2) AND low handgrip strength (Cutoff: Male < 28kg, Female <18 kg) OR low physical performance (6-metre walk, cutoff: <1.0m/s or 5-time chair stand test >=12s)
- Diagnosed with a hip fracture from low-energy mechanism (e.g., falling from standing height) requiring an operation
- Willing and able to comply with study protocol including follow-up evaluations.
Who cannot join
- open fracture
- multiple fractures
- pathological fractures e.g., tumour, infection, etc.
- history of medication or disease affecting bone metabolism e.g., hypo/hyperthyroidism
- malignancy
- chairbound or bedbound (unable to perform assessments)
Show all 13Show fewer
- serious cognitive problems e.g., severe dementia (unable to agree for consent) - renal impairment with glomerular filtration rate <30 mL/min
- prior anti-osteoporotic medication e.g. bisphosphonates, denosumab, etc.
- active infection,
- severe malnutrition i.e. Mini Nutritional Assessment < 17 points
- serious neurological or neuromuscular conditions e.g. Parkinson's disease
- uncontrolled chronic conditions e.g. poorly controlled diabetes mellitis
- not anaesthetically fit for operation or conservative management
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
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: RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients: A Pragmatic, Randomized Double-blind, Active-Controlled Trial
The objective of this study is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures.
Read the detailed description
Objectives
- To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of physical performance and quality of life.
- To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of appendicular skeletal muscle mass and muscle strength.
- To investigate the efficacy of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of falls, hospital re-admissions, re-fractures, and mortality.
- Conditions
- Sarcopenia in Elderly
- Being tested
- Denosumab (Prolia), Zoledronic acide (Aclasta)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab (Prolia)Drug
60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly
Zoledronic acide (Aclasta)Drug
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 (Prolia) |
| Zolendronic acid group | Placebo comparator | 5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months Receives: Drug: Zoledronic acide (Aclasta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia and Quality of Life (SarQoL®)
Health-related questionnaire for sarcopenia which is composed of 55 items translated into 22 questions and organized into seven domains of quality of life including physical and mental health, locomotion, body composition, functionality, activities of daily living, leisure activities, and fears. The SarQoL involves an overall score, which is the sum of seven individual domain scores, with higher scores indicating better quality of life. During the scoring process, the overall and domain scores are rescaled such that their maximum possible values become 100.
Measured: From enrolment to 24 months after the start of treatment
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 subject will push the leg forward with maximum force. Measurements are repeated three times and maximum value used for evaluation
Measured: From enrolment to 24 months after the start of treatment
Handgrip strength
Assessed by handgrip strength with spring-type hand dynamometer (JAMAR Hand Dynamometer 5030JO; Sammons Preston, Bolingbrook, IL). The maximum reading of 2 trials using the dominant hand in a maximum-effort isometric contraction is taken. Male < 28kg, and female <18kg are cut-off for low handgrip strength
Measured: From enrolment to 24 months after the start of treatment
Appendicular skeletal muscle mass (ASM)
Determined with Dual-energy X-ray absorptiometry (Horizon®, Hologic, USA). Total appendicular skeletal mass (ASM) 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 appendicular skeletal mass index (ASMI) (kg/m2). Cutoff of low ASMI is defined as Male <7.0kg/m2, and female <5.4kg/m2.
Measured: From enrolment to 24 months after the start of treatment
5-time chair stand test
The time to rise from a chair 5 times is recorded. Low physical performance is ≥ 12 seconds.
Measured: From enrolment to 24 months after the start of treatment
6-metre walk
The time taken to walk 6 metres without deceleration is taken. The average result of 2 trials is taken and recorded. Low physical performance is <1.0m/s
Measured: From enrolment to 24 months after the start of treatment
Short Physical Performance Battery
Performed by balance test (side-by-side stand, semi-tandem stand, and tandem stand), gait speed test (time for 4-meter walk), and chair stand test (5 repeats). Low physical performance is ≤ 9.
Measured: From enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
Secondary outcomes (5)
Falls
Patients self-report via fall calendar, which will be returned at each follow-up. Calendar reporting has been well proven to be reliable for fall studies
Measured: From enrolment to 24 months after the start of treatment
Hospital re-admissions
Documented from Clinical Management System (CMS) from Hospital Authority (public computerized system for all patients)
Measured: From enrolment to 24 months after start of treatment
Secondary fracture
Confirmed via X-ray/radiology report and Clinical Management System (CMS). Lateral X-ray of spine also taken during follow-up to detect the often clinically silent vertebral fracture. Vertebra is assessed by Genant classification as per our previously established protocol
Measured: From enrolment to 24 months after start of treatment
Mortality
Documented from the Clinical Management System (CMS) from Hospital Authority (public computerized system for all patients)
Measured: From enrolment to 24 months after start of treatment
Bone mineral density (BMD)
Measured by Dual-energy X-ray absorptiometry (Horizon®, Hologic, US) at lumbar spine and contralateral hip
Measured: From enrolment to 24 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Man Yeung WONG, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056478
- Sponsor's protocol ID
- 2023.401
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients: A Pragmatic, Randomized Double-blind, Active-Controlled Trial
- ClinicalTrials.gov ID
- NCT07056478
- Acronym / sponsor ID
- 2023.401
- Conditions
- Sarcopenia in Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 9 Jul 2025 (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 is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures.
Detailed description
Objectives
- To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of physical performance and quality of life.
- To investigate the effect of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of appendicular skeletal muscle mass and muscle strength.
- To investigate the efficacy of RANKL inhibition in treating sarcopenia in hip fracture patients in terms of falls, hospital re-admissions, re-fractures, and mortality.
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: Denosumab (Prolia)60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly |
| Zolendronic acid group | Placebo comparator | Drug: Zoledronic acide (Aclasta)5mg 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 (4 listed)
- Elderly aged 65 years or older
- Diagnosed with sarcopenia following AWGS guidelines - low appendicular skeletal muscle mass measured by dual-energy x-ray absorptiometry (Cutoff: Male <7.0kg/m2, and female <5.4kg/m2) AND low handgrip strength (Cutoff: Male < 28kg, Female <18 kg) OR low physical performance (6-metre walk, cutoff: <1.0m/s or 5-time chair stand test >=12s)
- Diagnosed with a hip fracture from low-energy mechanism (e.g., falling from standing height) requiring an operation
- Willing and able to comply with study protocol including follow-up evaluations.
Key exclusion criteria (13 listed)
- open fracture
- multiple fractures
- pathological fractures e.g., tumour, infection, etc.
- history of medication or disease affecting bone metabolism e.g., hypo/hyperthyroidism
- malignancy
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 |
|---|---|---|
| Denosumab (Prolia)60mg subcutaneous Denosumab (1mL solution) every 6 months and intravenous placebo (100mL normal saline) once yearly | Drug | Denosumab group |
| Zoledronic acide (Aclasta)5mg intravenous Zoledronic Acid (100mL solution) once yearly and subcutaneous placebo (1mL normal saline) every 6 months | Drug | Zolendronic acid group |
Primary outcome
Sarcopenia and Quality of Life (SarQoL®)
Time frame: From enrolment to 24 months after the start of treatment
Health-related questionnaire for sarcopenia which is composed of 55 items translated into 22 questions and organized into seven domains of quality of life including physical and mental health, locomotion, body composition, functionality, activities of daily living, leisure activities, and fears. The SarQoL involves an overall score, which is the sum of seven individual domain scores, with higher scores indicating better quality of life. During the scoring process, the overall and domain scores are rescaled such that their maximum possible values become 100.
Quadriceps muscle strength
Time frame: From enrolment to 24 months after the start of treatment
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 subject will push the leg forward with maximum force. Measurements are repeated three times and maximum value used for evaluation
Handgrip strength
Time frame: From enrolment to 24 months after the start of treatment
Assessed by handgrip strength with spring-type hand dynamometer (JAMAR Hand Dynamometer 5030JO; Sammons Preston, Bolingbrook, IL). The maximum reading of 2 trials using the dominant hand in a maximum-effort isometric contraction is taken. Male < 28kg, and female <18kg are cut-off for low handgrip strength
Appendicular skeletal muscle mass (ASM)
Time frame: From enrolment to 24 months after the start of treatment
Determined with Dual-energy X-ray absorptiometry (Horizon®, Hologic, USA). Total appendicular skeletal mass (ASM) 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 appendicular skeletal mass index (ASMI) (kg/m2). Cutoff of low ASMI is defined as Male <7.0kg/m2, and female <5.4kg/m2.
5-time chair stand test
Time frame: From enrolment to 24 months after the start of treatment
The time to rise from a chair 5 times is recorded. Low physical performance is ≥ 12 seconds.
6-metre walk
Time frame: From enrolment to 24 months after the start of treatment
The time taken to walk 6 metres without deceleration is taken. The average result of 2 trials is taken and recorded. Low physical performance is <1.0m/s
Short Physical Performance Battery
Time frame: From enrolment to 24 months after the start of treatment
Performed by balance test (side-by-side stand, semi-tandem stand, and tandem stand), gait speed test (time for 4-meter walk), and chair stand test (5 repeats). Low physical performance is ≤ 9.
Balancing ability
Time frame: From enrolment to 24 months after the start of treatment
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).
Balancing ability
Time frame: From enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
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 enrolment to 24 months after the start of treatment
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 (%).
5 secondary outcomes
Falls
Time frame: From enrolment to 24 months after the start of treatment
Hospital re-admissions
Time frame: From enrolment to 24 months after start of treatment
Secondary fracture
Time frame: From enrolment to 24 months after start of treatment
Mortality
Time frame: From enrolment to 24 months after start of treatment
Bone mineral density (BMD)
Time frame: From enrolment to 24 months after the start of treatment
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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 3 study testing Denosumab (Prolia) and Zoledronic acide (Aclasta) 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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Sarcopenia and Quality of Life (SarQoL®) (time frame: From enrolment to 24 months after the start of treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.