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

Primary Purpose

Hepatitis C, Chronic, Liver Diseases, Virus Diseases

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
peginterferon alfa-2a and ribavirin
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatitis C, Chronic focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • University Hospital Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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

Chronic hepatitis C patients without standard antiviral therapy

Outcomes

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

Secondary Outcome Measures

Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.

Full Information

First Posted
July 24, 2009
Last Updated
June 6, 2011
Sponsor
University of Ulm
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00948220
Brief Title
Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulm
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic, Liver Diseases, Virus Diseases
Keywords
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin
Arm Title
Control
Arm Type
No Intervention
Arm Description
Chronic hepatitis C patients without standard antiviral therapy
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a and ribavirin
Other Intervention Name(s)
Pegasys, Copegus
Intervention Description
standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.
Time Frame
96 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fuchs, MD
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

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

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