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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Liver Diseases
Virus Diseases
 Drug: peginterferon alfa-2a and ribavirin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: July 2003
Study Completion Date: March 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin
 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
No Intervention: Control
Chronic hepatitis C patients without standard antiviral therapy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948220

Locations
Germany
University Hospital Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Hoffmann-La Roche
Investigators
Principal Investigator: Michael Fuchs, MD University of Ulm
  More Information

No publications provided

Responsible Party: Dr. med. D. Klass, Universitätsklinikum Ulm
ClinicalTrials.gov Identifier: NCT00948220     History of Changes
Other Study ID Numbers: OSTEO
Study First Received: July 24, 2009
Last Updated: June 6, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
HCV
hepatitis C virus
CHC
chronic hepatitis c
interferon
ribavirin
DEXA
BMD
bone mineral density
 osteoporosis
osteopenia
osteodystrophy
osteodensitometry
Bone Density
Hepatitis, Viral, Human
Anti-Infective Agents
peginterferon alfa-2a

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Virus Diseases
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Peginterferon alfa-2a
Anti-Infective Agents
Ribavirin
Interferon-alpha
Antiviral Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013