Overview

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

Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Ulm
Collaborator:
Hoffmann-La Roche
Treatments:
Antiviral Agents
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Criteria
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