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Can a bone drug rebuild muscle? trial tests denosumab for sarcopenia

NCT ID NCT07056478

Symptom relief Sponsor: Prince of Wales Hospital, Shatin, Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether denosumab, a drug usually used for bone loss, can improve muscle strength and quality of life in older adults with sarcopenia after a hip fracture. The trial enrolls 130 people aged 65 and older who have low muscle mass and weakness. Participants receive either denosumab injections every six months or zoledronic acid infusions once a year, and researchers measure changes in muscle strength, physical performance, and balance over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
denosumab, a drug that blocks a protein involved in bone breakdown, given as a shot every six months
What this could lead to
If denosumab helps, it could become a new way to treat muscle loss and weakness in older adults recovering from a hip fracture, improving their strength and daily function.
What could go wrong
The trial is relatively small and focuses on a specific group of patients after hip fracture, so results may not apply to other people with sarcopenia. Denosumab can lower calcium levels and increase infection risk, and it is not yet proven to build muscle.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

hip fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sarcopenia in elderly

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Chinese University of Hong Kong

    Hong Kong, China

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