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

University of Ulm

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic; Virus Diseases; Liver Diseases

Treatments: Drug: peginterferon alfa-2a and ribavirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00948220

OSTEO

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Treatment

Experimental group

Description:

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

Treatment:

Drug: peginterferon alfa-2a and ribavirin

Control

No Intervention group

Description:

Chronic hepatitis C patients without standard antiviral therapy