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

June 6, 2011 updated by: University of Ulm

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • University Hospital Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin
Drug: peginterferon alfa-2a and ribavirin
standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d
Other Names:
  • Pegasys
  • Copegus
No Intervention: Control
Chronic hepatitis C patients without standard antiviral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 96 weeks
96 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.
Time Frame: 96 weeks
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Michael Fuchs, MD, University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Estimate)

June 7, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSTEO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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