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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948220
• Other study ID #: OSTEO
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2009
• Last updated: June 6, 2011
• Start date: July 2003
• Est. completion date: March 2008

Study information

• Verified date: May 2011
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Liver Diseases
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.		96 weeks	No