Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-03 @ 1:17 PM
Study NCT ID:
NCT02891356
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2016-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA)', 'timeFrame': '4 years', 'description': 'measured the evolution of the bone mineral density in 180 anorexia nervosa patients and the relationship with this change and adipokine'}], 'secondaryOutcomes': [{'measure': 'Incidence of osteoporotic fractures', 'timeFrame': 'at 2,4 and 6 years'}, {'measure': 'Adiponectin plasma concentration by ELISA', 'timeFrame': 'at 2,4 and 6 years', 'description': 'measurement of circulating biological factors predicative of changes in BMD'}, {'measure': 'Interleukin-7 plasma concentration by ELISA', 'timeFrame': 'at 2,4 and 6 years', 'description': 'measurement of circulating biological factors predicative of changes in BMD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adiponectin', 'Bone remodelling markers'], 'conditions': ['Anorexia Nervosa', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anorexia patient recruted in psychiatric unit ( hospitalisation and consultation visit)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anorexia patient defined by DSM IV diagnostic criteria\n\nExclusion Criteria:\n\n* patient with other psychiatric disease\n* patient with other a metabolic bone disease'}, 'identificationModule': {'nctId': 'NCT02891356', 'acronym': 'AMOS', 'briefTitle': 'Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.', 'orgStudyIdInfo': {'id': '2011_38'}, 'secondaryIdInfos': [{'id': '2012-A01009-34', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anorexia patient', 'description': 'Dual Energy X-ray Absorptiometry (DEXA)', 'interventionNames': ['Device: DEXA']}], 'interventions': [{'name': 'DEXA', 'type': 'DEVICE', 'description': 'The Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck', 'armGroupLabels': ['Anorexia patient']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Isabelle LEGROUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}