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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin |
|
| Control | No Intervention | Chronic hepatitis C patients without standard antiviral therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a and ribavirin | Drug | standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy. | 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fuchs, MD | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ulm | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D008107 | Liver Diseases |
| D014777 | Virus Diseases |
| D006526 | Hepatitis C |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D006525 | Hepatitis, Viral, Human |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018178 | Flaviviridae Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| D012327 |
| RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |