Effect of Long-Term Use of Tenofovir (TDF) on Bone Density in Patients With Chronic Hepatitis B
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorAssiut University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Study Population Age Range: 18 to 60 years Sex: Male and Female HBV Status: HBV-positive patients Treatment Duration: Long-term use of Tenofovir (TDF) for more than five years Sampling Method: Non-Probability Sampling Healthy Volunteers: Not Accepted
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TDF (Tenofovir)
DrugANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B VIRUS INFECTION
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Percent Change in Bone Mineral Density (BMD)
Change in BMD measured by dual-energy X-ray absorptiometry (DEXA), expressed as percentage change from baseline.
Time frame
Baseline to 5 years post-TDF initiationSponsors and contacts
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Source ClinicalTrials.gov
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