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

NCT06990438 | Not Yet Recruiting FDA Drug

• 1 other identifier: TDF ON BONE HEALTH
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tenofovir Disoproxil Fumarate; Bone Density; Chronic HBV Infection

Outcome Measures

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.

  Baseline to 5 years post-TDF initiation

Interventions

TDF (Tenofovir) DRUG

ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B VIRUS INFECTION

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• Presence of other chronic liver diseases.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assuit

Asyut, Egypt

Location

Related Publications (10)

• 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.

  PMID: 27915131 RESULT

• 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.

  PMID: 31314188 RESULT

• 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.

  PMID: 21076445 RESULT

• 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.

  PMID: 34731856 RESULT

• 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.

  PMID: 24954675 RESULT

• 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.

  PMID: 32102898 RESULT

• Chien RN, Liaw YF. Current Trend in Antiviral Therapy for Chronic Hepatitis B. Viruses. 2022 Feb 21;14(2):434. doi: 10.3390/v14020434.

  PMID: 35216027 RESULT

• 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.

  PMID: 12472227 RESULT

• 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.

  PMID: 26563120 RESULT

• 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.

  PMID: 26566064 RESULT

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

NOUR SHAABAN MOHAMED, RESIDENT

CONTACT

+0201122193390; NOUR.20124438@MED.AUN.EDU.EG

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: May 25, 2025
• Study Start: May 22, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

EG (1)