Impact of osteoporosis medications on fatty liver disease
Effect of Anti-osteoporotic Medications on Hepatic Steatosis and Fibrosis of Women with Postmenopausal Osteoporosis and Nonalcoholic Fatty Liver Disease
This study is testing if osteoporosis medications can help improve liver health in postmenopausal women who have both osteoporosis and nonalcoholic fatty liver disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Drugs / interventions | methotrexate, Denosumab |
| Locations | 3 sites (Thessaloniki and 2 other locations) |
| Trial ID | NCT05493761 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of anti-osteoporotic medications, specifically denosumab and alendronate sodium, on patients with nonalcoholic fatty liver disease (NAFLD) and osteoporosis. It aims to explore the potential benefits of these medications in improving liver health in postmenopausal women who are diagnosed with both conditions. The study will include participants who meet specific criteria related to bone density and liver health, and will assess the outcomes through non-invasive indices of hepatic steatosis. The goal is to determine if these osteoporosis treatments can also provide therapeutic effects for NAFLD.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women over 40 years old with a diagnosis of osteoporosis or osteopenia and nonalcoholic fatty liver disease.
Not a fit: Patients with significant alcohol consumption, chronic liver diseases, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients suffering from both osteoporosis and nonalcoholic fatty liver disease.
How similar studies have performed: While there is emerging evidence suggesting a link between osteoporosis medications and liver health, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Thessaloniki and 2 other locations
- 1st Department of Obstetrics and Gynecology, School, of Medicine, Aristotle University of Thessaloniki — Thessaloniki, Greece (Recruiting)
- Department of Endocrinology, "Hippokration" General Hospital of Thessaloniki — Thessaloníki, Greece (Recruiting)
- 424 General Military Hospital — Thessaloníki, Greece (Recruiting)
Study contacts
- Principal investigator: Stergios A Polyzos, MD, PhD — School of Medicine, Aristotle University of Thessaloniki
- Study coordinator: Stergios A Polyzos, MD, PhD
- Email: spolyzos@auth.gr
- Phone: 2310999316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.