Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-09 @ 1:59 AM
Study NCT ID:
NCT03994094
Status:
UNKNOWN
Last Update Posted:
2019-08-21
First Post:
2019-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D058866', 'term': 'Osteoporotic Fractures'}], 'ancestors': [{'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'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2019-06-20', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of fractures since the enrollment in the clinic', 'timeFrame': 'From the enrollment of patients between january 2012 and december 2015 to the interview date', 'description': 'Number of incident fractures suffered by the patient since their enrollment in the osteoporosis clinic.'}], 'secondaryOutcomes': [{'measure': 'Evolution of bone mineral density since the enrollment in the clinic', 'timeFrame': 'From the enrollment of patients between january 2012 and december 2015 to the interview date', 'description': 'Evolution of the bone mineral density since their enrollment in the osteoporosis clinic'}, {'measure': 'Satisfaction with the osteoporosis clinic', 'timeFrame': 'From the enrollment of patients between january 2012 and december 2015 to the interview date', 'description': 'Level of satisfaction measured with a four level Lickert scale ( Very satisfied ? Satisfied? Unsatisfied? Dissatisfied?)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Osteoporotic Fractures']}, 'descriptionModule': {'briefSummary': 'A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis.\n\nThe effectiveness specialized osteoporosis clinics is the subject of numerous publications.\n\nIt therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who were enrolled in the cohort of the osteoporosis clinic of our hospital between january 2012 and December 2015 following an osteoporotic fracture.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015\n* Acceptation of the telephone interview\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* No social security coverage'}, 'identificationModule': {'nctId': 'NCT03994094', 'briefTitle': 'Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures', 'orgStudyIdInfo': {'id': 'CHM-2019-S7/01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Telephone interview', 'type': 'OTHER', 'description': 'Structured, directive, telephone interview, in order to collect the outcome measures in addition to the patients electronic health record.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Hospitalier Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'overallOfficials': [{'name': 'Bénédicte Haettich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier du Mans, Rheumatology Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}