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Bone drugs may double as liver fat fighters — a trial puts them to the test

NCT ID NCT05493761

Disease control Sponsor: Aristotle University Of Thessaloniki Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial investigates whether two common osteoporosis medications, denosumab and alendronate, can reduce liver fat and scarring in postmenopausal women who also have nonalcoholic fatty liver disease (NAFLD). The study will compare changes in liver fat and stiffness over 12 months in women receiving either drug. If denosumab proves effective, it could offer a new treatment avenue for NAFLD, a condition with no approved medications.

What this could mean

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

Active substance
denosumab or alendronate (anti-osteoporosis medications)
What this could lead to
If denosumab reduces liver fat and fibrosis, it could point toward a new use for an existing osteoporosis drug in treating NAFLD.
What could go wrong
This is a small, non-randomized study, so results may not be conclusive. Denosumab can cause side effects like bone or joint pain, and its effect on the liver is still uncertain.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

72 people

The number who actually took part.

Started

Dec 2022

Finished

Jul 2026

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

40 years and older

Sex

Female participants only

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: * postmenopausal women aged \> 40 years * diagnosis of osteoporosis, or osteopenia and Fracture Assessment Risk (FRAX) score indicative for initiation of anti-osteoporotic treatment, or osteopenia and history of low-energy fracture. Evaluation of osteopenia and osteoporosis will be based on bone mineral density (BMD) of the lumbar spine and/or the femoral neck of the non-dominant hip measured with dual energy X-ray absorptiometry (DXA) * diagnosis of NAFLD based on non-invasive indices of hepatic steatosis * written informed consent Exclusion Criteria: * mean ethanol consumption \>10 g/day * a history of other chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis and overlap syndromes, drug-induced liver injury, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency) * liver cirrhosis * any malignancy * chronic kidney disease * uncontrolled hypothyroidism or hyperthyroidism * use of the following medications within a 12-month period before baseline associated with drug-induced fatty liver: interferon, tamoxifen, amiodarone, aloperidin, glucocorticosteroids, anabolic steroids, any medication against tuberculosis, epilepsy or viruses, methotrexate, parenteral nutrition * use of the following medications within a 12-month period before baseline associated probably with improvement in fatty liver: vitamin E, pioglitazone, insulin, glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium-glucose co-transporter-2 inhibitors (SGLT-2), orlistat, ursodeoxycholic acid * use of any anti-osteoporotic medication within a 12-month period before baseline, except for calcium and vitamin D

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fatty liver disease metabolic dysfunction-associated steatotic liver disease postmenopausal osteoporosis

As listed by the trial registrant

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

Nonalcoholic fatty liver Osteoporosis postmenopausal

Contacts and locations

Locations

  • 1st Department of Obstetrics and Gynecology, School, of Medicine, Aristotle University of Thessaloniki

    Thessaloniki, 56403, Greece

  • 424 General Military Hospital

    Thessaloniki, 56429, Greece

  • Department of Endocrinology, "Hippokration" General Hospital of Thessaloniki

    Thessaloniki, 54642, Greece

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