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Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C

Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic; Liver Diseases; Virus Diseases

Intervention: peginterferon alfa-2a and ribavirin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Ulm

Official(s) and/or principal investigator(s):
Michael Fuchs, MD, Principal Investigator, Affiliation: University of Ulm


One single study has suggested that bone mineral density (BMD) is reduced in patients with non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard interferon and ribavirin may further decrease BMD. The aim of this study is to systematically investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.

Clinical Details

Official title: Non-randomized Prospective Study on the Effect of Antiviral Therapy With Peginterferon Alfa-2a and Ribavirin on Bone Mineral Density and Metabolism in Patients With Chronic Viral Hepatitis C Genotype 1

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Change of the bone mineral density of the lumbar spine and right hip measured by DEXA in patients with chronic hepatitis C with or without antiviral combination treatment with peginterferon and ribavirin

Secondary outcome: Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.


Inclusion Criteria:

- proven chronic hepatitis C

- aged between 18 and 65

- male patients

Exclusion Criteria:

- high grade liver fibrosis (Grade 3 - 4)

- renal disease

- hyperparathyroidism

- hypogonadism

- malignant disease

- use of any other drug known to effect bone mineral metabolism

- use of alcohol

- organ transplant

- any form of thyroid disease

- any medical condition known to be associated with bone loss

Locations and Contacts

University Hospital Ulm, Ulm 89081, Germany
Additional Information

Starting date: July 2003
Last updated: June 6, 2011

Page last updated: August 23, 2015

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