Objective: To compare the risk of pathologic bone fractures between Tenofovir and Entecavir in chronic hepatitis B patients.

Rationale: Tenofovir disoproxil fumarate (TDF) and entecavir are the treatment of choices for chronic hepatitis B patients. Modest decreases in bone mineral density (BMD) have been observed in antiretroviral therapy taking TDF in chronic hepatitis B patients. The exact mechanism of TDF-induced BMD loss is not well understood although studies have shown that it could be due to effects on bone metabolism or renal tubular dysfunction. Whereas tenofovir exposure has been associated with decreased bone density and some studies in HIV-infected persons have shown increased risk for fractures or osteomalacia from TDF use, it remains unclear whether it is associated with increased risk of fractures or not in chronic hepatitis B patients. So, we will conduct study head to head comparison between tenofovir and entecavir on the risk of bone fracture events in chronic hepatitis B patients using OHDSI network data base. 

Project Lead(s): Youn-i Choi, MD, KGil Medical Center; Seng Chan You, MD, Ajou University, Korea

Coordinating Institution(s): Ajou University; Kangwon National University Hospital

Additional Participants:

Full Protocol:

Initial Proposal Date: 24th Jan 2018

Launch Date:

Study Closure Date:

Results Submission: applegna@gmail.com