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

Study Overview
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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.

Official Title
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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

Conditions
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Hepatitis C, Chronic, Liver Diseases, Virus Diseases

Intervention / Treatment
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* Drug: peginterferon alfa-2a and ribavirin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin | Drug: peginterferon alfa-2a and ribavirin<br>* standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d<br>* Other names: Copegus;|
| No Intervention: Control<br>Chronic hepatitis C patients without standard antiviral therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 96 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, hepatitis C virus, CHC, chronic hepatitis c, interferon, ribavirin, DEXA, bone mineral density, osteoporosis, osteopenia, osteodystrophy, osteodensitometry, Bone Density, Hepatitis, Viral, Human, Anti-Infective Agents, peginterferon alfa-2a, BMD