Effect of Long-Term Use of Tenofovir (TDF) on Bone Density in Patients With Chronic Hepatitis B
NCT ID: NCT06990438
Last Updated: 2025-05-25
Study Results
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Basic Information
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NOT_YET_RECRUITING
172 participants
OBSERVATIONAL
2025-05-22
2026-06-01
Brief Summary
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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.
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Detailed Description
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The diagnosis of Chronic Hepatitis B (CHB) is established by the persistence of Hepatitis B surface antigen (HBsAg) for more than six months . Some patients with chronic HBV infection may experience acute exacerbation, potentially progressing to acute-on-chronic liver failure (ACLF), a condition with a high mortality rate despite intensive supportive care and resource utilization. While liver transplantation is considered a potential life-saving treatment for ACLF, its widespread clinical application is limited due to donor shortages and high financial costs. Therefore, early intervention and treatment are crucial in managing patients with ACLF .
The primary goals of antiviral therapy in CHB are to suppress viral replication and promote the loss of HBV-related antigens . Currently, there are two major classes of antiviral agents approved for treating CHB: Interferon-Alpha and Nucleos(t)ide Analogues (NUCs). Among the NUCs, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), and Tenofovir Alafenamide (TAF) are the most widely used first-line treatments. These agents are effective, orally administered, and generally well-tolerated. However, long-term treatment is often required, as premature discontinuation may lead to virological relapse and liver failure.
TDF is considered one of the most potent antiviral agents against both HBV and HIV. However, it has been associated with bone toxicity, primarily through the development of osteoporosis via multiple mechanisms. Intracellular accumulation of TDF can lead to proximal tubular dysfunction and Fanconi syndrome, resulting in hypophosphatemic osteomalacia . Additionally, TDF has been shown to reduce osteoblast gene expression, impairing osteoblast function and decreasing bone formation .
Moreover, TDF-induced reduction in phosphate reabsorption in the proximal renal tubules can lead to bone disease, including hypouricemia and hypophosphatemia, ultimately contributing to osteomalacia and an increased risk of fractures. In contrast, TAF exhibits greater plasma stability, and therefore, its impact on renal and bone toxicity may be significantly lower
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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TDF (Tenofovir)
ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B VIRUS INFECTION
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
Diagnosed with Chronic Kidney Disease (CKD), regardless of etiology.
Patients who refuse to participate in the study.
Patients on combination therapy, including:
Interferon and Nucleoside analogue combination therapy.
Multiple nucleoside analogue combination therapy.
\-
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Nour shaaban Mohamed Abd elrasoul
Principal Investigator
Locations
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Faculty of Medicine, Assuit
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Han Y, Zeng A, Liao H, Liu Y, Chen Y, Ding H. The efficacy and safety comparison between tenofovir and entecavir in treatment of chronic hepatitis B and HBV related cirrhosis: A systematic review and Meta-analysis. Int Immunopharmacol. 2017 Jan;42:168-175. doi: 10.1016/j.intimp.2016.11.022. Epub 2016 Dec 1.
Kara AV, Yildirim Y, Ozcicek F, Aldemir MN, Arslan Y, Bayan K, Celen MK. Effects of entecavir, tenofovir and telbivudine treatment on renal functions in chronic hepatitis B patients. Acta Gastroenterol Belg. 2019 Apr-Jun;82(2):273-277.
Perazella MA. Tenofovir-induced kidney disease: an acquired renal tubular mitochondriopathy. Kidney Int. 2010 Dec;78(11):1060-3. doi: 10.1038/ki.2010.344.
Jeong S, Shin HP, Kim HI. Real-World Single-Center Comparison of the Safety and Efficacy of Entecavir, Tenofovir Disoproxil Fumarate, and Tenofovir Alafenamide in Patients with Chronic Hepatitis B. Intervirology. 2022;65(2):94-103. doi: 10.1159/000519440. Epub 2021 Nov 3.
Trepo C, Chan HL, Lok A. Hepatitis B virus infection. Lancet. 2014 Dec 6;384(9959):2053-63. doi: 10.1016/S0140-6736(14)60220-8. Epub 2014 Jun 18.
Nguyen MH, Wong G, Gane E, Kao JH, Dusheiko G. Hepatitis B Virus: Advances in Prevention, Diagnosis, and Therapy. Clin Microbiol Rev. 2020 Feb 26;33(2):e00046-19. doi: 10.1128/CMR.00046-19. Print 2020 Mar 18.
Chien RN, Liaw YF. Current Trend in Antiviral Therapy for Chronic Hepatitis B. Viruses. 2022 Feb 21;14(2):434. doi: 10.3390/v14020434.
Castillo AB, Tarantal AF, Watnik MR, Martin RB. Tenofovir treatment at 30 mg/kg/day can inhibit cortical bone mineralization in growing rhesus monkeys (Macaca mulatta). J Orthop Res. 2002 Nov;20(6):1185-9. doi: 10.1016/S0736-0266(02)00074-8.
Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.
Terrault NA, Bzowej NH, Chang KM, Hwang JP, Jonas MM, Murad MH; American Association for the Study of Liver Diseases. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016 Jan;63(1):261-83. doi: 10.1002/hep.28156. Epub 2015 Nov 13. No abstract available.
Other Identifiers
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TDF ON BONE HEALTH
Identifier Type: -
Identifier Source: org_study_id
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