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

Condition(s) studied

Investigational drug(s) / intervention(s)

TDF (Tenofovir): ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B VIRUS INFECTION

Study 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.

Eligibility

Primary outcome measure(s)

• Percent Change in Bone Mineral Density (BMD) — Baseline to 5 years post-TDF initiation
  Change in BMD measured by dual-energy X-ray absorptiometry (DEXA), expressed as percentage change from baseline.

Trial sites (1)

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