Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT01556360
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2012-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006432', 'term': 'Hemochromatosis'}, {'id': 'D019190', 'term': 'Iron Overload'}], 'ancestors': [{'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* serum\n* urine\n* DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-15', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': 'Change from baseline in bone mineral density at three years', 'description': 'Vertebral and hips Dual energy X-ray Absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Predictive value of iron overload on Bone Mineral Density', 'timeFrame': '1 day'}, {'measure': 'Number of vertebral fractures', 'timeFrame': '3 years'}, {'measure': 'Number of peripheral fractures', 'timeFrame': '3 years'}, {'measure': 'Number and location of joint lesions detected by the examination (pain and swelling)', 'timeFrame': '3 years'}, {'measure': 'Determination of genetic polymorphism of BMP 2 and 4', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genetic hemochromatosis', 'Iron overload', 'C282 homozygosity'], 'conditions': ['Genetic Hemochromatosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.', 'detailedDescription': 'Bone diseases have been recognized recently as complications of genetic hemochromatosis. Further studies are needed to describe the role of iron in bone injuries. The purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with genetic hemochromatosis diagnosed in western France hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 80 years\n* C282 homozygosity\n\nExclusion Criteria:\n\n* corticosteroids during the last 3 months\n* following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.\n* following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate.\n* cancer or evolutionary hemopathy (including monoclonal gammopathy)\n* pregnancy at inclusion time\n* treated osteoporosis\n* patient in wich follow up seems hard\n* inclusion in another study incompatible with this one'}, 'identificationModule': {'nctId': 'NCT01556360', 'acronym': 'FEROS', 'briefTitle': 'Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.', 'orgStudyIdInfo': {'id': '2008-A000386-47'}}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Brest University Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'facility': 'Orleans Regional Hospital', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Guggenbuhl Pascal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}