Clinical Trial

Effect of Long-Term Use of Tenofovir (TDF) on Bone Density in Patients With Chronic Hepatitis B

Not Yet Recruiting
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Record status
This record was last updated May 25, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to evaluate the effect of long-term use of Tenofovir Disoproxil Fumarate (TDF) on bone density in patients with chronic hepatitis B virus (HBV) infection. Tenofovir is a widely used antiviral medication for the treatment of HBV. While it is generally well tolerated, some studies have reported potential adverse effects on bone mineral density, particularly with long-term use. The objective of this research is to assess whether extended TDF therapy is associated with reduced bone density or increased risk of osteopenia or osteoporosis in adult patients with chronic HBV infection. The study will involve clinical evaluation and radiological assessment of bone health using dual-energy X-ray absorptiometry (DEXA) scans, as well as relevant biochemical markers. This investigation will provide important data on the long-term safety profile of Tenofovir in relation to bone health and help guide future clinical decisions for the management of chronic hepatitis B.
Trial Details
NCT Number NCT06990438
Lead Sponsor Assiut University
Conditions Tenofovir Disoproxil Fumarate, Bone Density, Chronic HBV Infection
Enrollment 172 participants
Start Date 2025-05-22
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-25