Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Aug 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two anti-osteoporotic medications—denosumab and bisphosphonates—on nonalcoholic fatty liver disease (NAFLD) in postmenopausal women who also have osteoporosis. NAFLD is a condition where too much fat builds up in the liver, and it's often linked to obesity and diabetes. The trial aims to see if denosumab, which is already used to treat osteoporosis, can also help improve liver health in women with both osteoporosis and NAFLD, while bisphosphonates are expected to have little effect on the liver.

To be eligible for this trial, participants must be postmenopausal women over 40 years old with a diagnosis of osteoporosis or a risk of fractures. They must also have a diagnosis of NAFLD based on specific tests. Before joining, women will need to provide their written consent. Throughout the trial, participants will receive either denosumab or bisphosphonates, and their liver condition will be monitored. This study is actively recruiting participants, and it offers a chance to contribute to new research that could help other women with similar health issues.

Gender

FEMALE

Eligibility 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