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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00948220
First received: July 24, 2009
Last updated: June 6, 2011
Last verified: May 2011

July 24, 2009
June 6, 2011
July 2003
January 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948220 on ClinicalTrials.gov Archive Site
Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hepatitis C, Chronic
  • Liver Diseases
  • Virus Diseases
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
  • Experimental: Treatment
    Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin
    Intervention: Drug: peginterferon alfa-2a and ribavirin
  • No Intervention: Control
    Chronic hepatitis C patients without standard antiviral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
March 2008
January 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00948220
OSTEO
No
Dr. med. D. Klass, Universitätsklinikum Ulm
University of Ulm
Hoffmann-La Roche
Principal Investigator: Michael Fuchs, MD University of Ulm
University of Ulm
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP