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

NCT ID: NCT00948220

Last Updated: 2011-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C, Chronic Liver Diseases Virus Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment

Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin

Group Type EXPERIMENTAL

peginterferon alfa-2a and ribavirin

Intervention Type DRUG

standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d

Control

Chronic hepatitis C patients without standard antiviral therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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peginterferon alfa-2a and ribavirin

standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Universitätsklinikum Ulm

Principal Investigators

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Michael Fuchs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

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University Hospital Ulm

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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OSTEO

Identifier Type: -

Identifier Source: org_study_id

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