Hepatitis C, Chronic, Liver Diseases, Virus Diseases
Conditions
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
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.
Interventions
standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d
Sponsors
Hoffmann-La Roche
University of Ulm
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy. | 96 weeks |
Countries
Germany
Outcome results
None listed