Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT00225004
Status:
TERMINATED
Last Update Posted:
2014-04-03
First Post:
2005-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Osteoporosis and Colles Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003100', 'term': "Colles' Fracture"}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D000072039', 'term': 'Fracture Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}}, 'statusModule': {'whyStopped': 'Recruiting problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2005-09-21', 'studyFirstSubmitQcDate': '2005-09-21', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of Osteoporosis ten years after a Colles Fracture', 'timeFrame': 'years'}, {'measure': 'The incidence of Osteoporosis in women with an actual Colles Fracture', 'timeFrame': 'years'}]}, 'conditionsModule': {'keywords': ['Colles Fracture', 'Osteoporosis', 'BMD', 'Quality assurance'], 'conditions': ['Previous or Actual Colles Fracture']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the retrospective study is to determine the incidence of osteoporosis in women with previous Colles Fracture. Secondly, to determine to which extent Colles Fracture has led to a diagnosis and/or treatment of osteoporosis.\n\nThe primary purpose of the prospective study is to determine the incidence of osteoporosis in women with an actual Colles Fracture. Secondly, to investigate the consistency between prospective and retrospective data.', 'detailedDescription': 'Colles Fracture is known to be connected to decreased bone mineral density (BMD). Thus, it can be an early sign of osteoporosis and therefore an increased risk of new fractures.\n\nThe results of earlier studies have not been unambiguous in the respect of what extent decreased BMD in the wrist of women with Colles Fracture is synonymous of osteoporosis in the spine and the hip.\n\nAn earlier enquiry to the Danish Orthopedic Departments in 1995 showed that only 18 % of the departments diagnosed or referred patients with possible osteoporosis.\n\nThe two study designs enhance the possibilities of evaluating the relevance of Low Energy Fractures in the wrist to avoid new fractures and their relation to bone mineral density.\n\nThe results could also be a useful tool in quality assurance of the osteoporosis diagnostics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nColles Fracture Women over 40 years Informed consent-\n\nExclusion Criteria:\n\nHigh Energy Fracture Deceases or conditions that makes the participant unable to contribute to the investigation-'}, 'identificationModule': {'nctId': 'NCT00225004', 'briefTitle': 'Osteoporosis and Colles Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Northern Orthopaedic Division, Denmark'}, 'officialTitle': 'Low-energy Fracture of the Wrist (Colles Fracture) and Osteoporosis. A Ten Year Follow-up and a Prospective Study', 'orgStudyIdInfo': {'id': 'ON-06-002-AJ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DEXA scan', 'type': 'PROCEDURE', 'description': 'orto'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'Jutland', 'country': 'Denmark', 'facility': 'The department of Orthopedic surgery Northern Jutland Counties, Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aalborg', 'state': 'Northern Jutland', 'country': 'Denmark', 'facility': 'Northern Orthopaedic Division, Klinik Aalborg', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Klaus K Pedersen, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Orthopedic Northern Jutland Counties, Denmark'}, {'name': 'Klaus K Pedersen, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopedic surgery, Northern Jutland Counties, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Orthopaedic Division, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}