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NCT06990438Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
172 (estimated)
First submitted
17 May 2025
Start date
22 May 2025
Primary completion date
1 May 2026
Lead sponsor
Assiut University
Diseases
Hepatitis B
NCT number
NCT06990438

What you commit to

  • Study type: Observational
  • Planned participants: 172
  • From 22 May 2025 to the primary completion date, 1 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients on combination therapy, including:
  • Interferon and Nucleoside analogue combination therapy.
  • Multiple nucleoside analogue combination therapy.

Other illness

  • Presence of other chronic liver diseases.
  • Diagnosed with Chronic Kidney Disease (CKD), regardless of etiology.

Other

  • Patients who refuse to participate in the study.
  • \-

Who the study is looking for

  • \-
  • Adult male or female patients aged 18 to 60 years.
  • Diagnosed as HBV-positive.
  • Long-term use of Tenofovir Disoproxil Fumarate (TDF) for more than five years.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Faculty of Medicine, Assuit
Coordinator of this site? Confirm its status
AsyutEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.