Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00948220
Status:
COMPLETED
Last Update Posted:
2011-06-07
First Post:
2009-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '96 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.', 'timeFrame': '96 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['Hepatitis C, Chronic', 'Liver Diseases', 'Virus Diseases']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proven chronic hepatitis C\n* aged between 18 and 65\n* male patients\n\nExclusion Criteria:\n\n* high grade liver fibrosis (Grade 3 - 4)\n* renal disease\n* hyperparathyroidism\n* hypogonadism\n* malignant disease\n* use of any other drug known to effect bone mineral metabolism\n* use of alcohol\n* organ transplant\n* any form of thyroid disease\n* any medical condition known to be associated with bone loss'}, 'identificationModule': {'nctId': 'NCT00948220', 'briefTitle': 'Influence of Antiviral Therapy on Bone Mineral Density and Metabolism in Patients With Chronic Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OSTEO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin', 'interventionNames': ['Drug: peginterferon alfa-2a and ribavirin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Chronic hepatitis C patients without standard antiviral therapy'}], 'interventions': [{'name': 'peginterferon alfa-2a and ribavirin', 'type': 'DRUG', 'otherNames': ['Pegasys', 'Copegus'], 'description': 'standard antiviral therapy with peginterferon alfa-2a 180 µg/week and ribavirin 1000-1200 mg/d', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University Hospital Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Michael Fuchs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. med. D. Klass', 'oldOrganization': 'Universitätsklinikum Ulm'}}}}