Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C
Phase 4
Completed
- Conditions
- Hepatitis C, ChronicLiver DiseasesVirus Diseases
- Interventions
- Registration Number
- NCT00948220
- Lead Sponsor
- University of Ulm
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment peginterferon alfa-2a and ribavirin Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy. 96 weeks
Trial Locations
- Locations (1)
University Hospital Ulm
🇩🇪Ulm, Germany