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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
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
Locations and Contacts
University Hospital Ulm, Ulm 89081, Germany
Additional Information
Starting date: July 2003
Last updated: June 6, 2011
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