Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-17 @ 12:41 PM
Study NCT ID:
NCT04151732
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2019-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Future Fractures in Middle-aged Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D062789', 'term': 'Tobacco Products'}, {'id': 'D000082742', 'term': 'Heart Disease Risk Factors'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D012307', 'term': 'Risk Factors'}, {'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015984', 'term': 'Causality'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30351}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any fracture', 'timeFrame': '1992 - 2017', 'description': 'Number of patients who suffered any fracture during follow-up (ICD-10 codes S12.x, S22.x, S32.x, S42.x, S52.x, S62.x, S32.x, S72.x, M48.4, M84.3, and M96.6)'}], 'secondaryOutcomes': [{'measure': 'Multiple fractures', 'timeFrame': '1992 - 2017', 'description': 'Number of patients who suffered multiple fractures during follow-up (ICD-10 codes S12.x, S22.x, S32.x, S42.x, S52.x, S62.x, S32.x, S72.x, M48.4, M84.3, and M96.6)'}, {'measure': 'Death', 'timeFrame': '1992 - 2017', 'description': 'Number of patients who died during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fractures, Bone', 'Fragility', 'Life Style']}, 'referencesModule': {'references': [{'pmid': '35974320', 'type': 'DERIVED', 'citation': 'Moberg L, Hamrefors V, Fedorowski A, Rogmark C. Early menopause and weight loss are significant factors associated with risk of future fracture in middle-aged women. BMC Musculoskelet Disord. 2022 Aug 16;23(1):779. doi: 10.1186/s12891-022-05744-5.'}, {'pmid': '33598954', 'type': 'DERIVED', 'citation': 'Rogmark C, Fedorowski A, Hamrefors V. Physical Activity and Psychosocial Factors Associated With Risk of Future Fractures in Middle-Aged Men and Women. J Bone Miner Res. 2021 May;36(5):852-860. doi: 10.1002/jbmr.4249. Epub 2021 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'From prospectively collected health and life-style data and anthropometric data in the Malmo Diet and Cancer (MDC) cohort identify factors that predicts or are associated with forthcoming fracture in middle-aged men and women.', 'detailedDescription': "In adults, the incidence of fractures increases with age. In predisposed individuals, even a minor trauma can result in a fracture. Such an injury is known as low-energy fracture or fragility fracture, and the risk increases with age. Fragility fractures may be preventable, either by changes in lifestyle or by medication of underlying diseases. Fragility fractures also put a burden both on the affected individual and on society. As the population age, more individuals are at risk, and the absolute numbers of fragility fractures increase. Therefore, identification of individuals at risk before fracture occurs would be ideal.In the prospectively collected Malmo Diet and Cancer (MDC) cohort a large number of health and life style variables have been gathered from randomly invited men and women in a city of 350,000 inhabitants in the 1990s'. The MDC database the investigators use for this study comprises 30,351 participants. Outcome is updated via crosslinking with the National Patient Register in Sweden.\n\nMDC PhysFract - investigation of the following factors Socioeconomical factors: Level of education, employment status in middle age, physical activity / work load, living alone, stress, number of friends, feeling of loneliness.\n\nLife style factors: Tobacco use, alcohol use. Summary of physical and psychological well-being.\n\nMDC CardFract - investigation of the following factors Comorbidities: Hypertension, syncope/orthostatism, diabetes, coronary artery disease, atrial fibrillation, heart failure, ischemic stroke and others.\n\nPharmaceutical drugs associated with fracture risk. Cardiovascular blood tests.\n\nMDC HormFract - investigation of the following factors Body composition: Weight at 20 yrs, weight change pattern, weight difference middle age minus 20 yrs.\n\nHormonal/gynecological status - women: Date for menarche and menopause, number of children, intake of oral contraceptives / hormonal replacement therapy, surgical menopause."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30,351', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Invited population based cohort from 1990's\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT04151732', 'acronym': 'MDCFract', 'briefTitle': 'Factors Associated With Future Fractures in Middle-aged Men and Women', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Factors Associated With Future Fractures in Middle-aged Men and Women. A Prospective Cohort Study From Malmö Dietary Cancer Cohort', 'orgStudyIdInfo': {'id': 'MDCFract1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Physical activity, alcohol, tobacco', 'type': 'BEHAVIORAL', 'description': "Physical activity, alcohol, tobacco - selfreported in the 1990's"}, {'name': 'Hormonal factors', 'type': 'OTHER', 'description': "Hormonal factors - selfreported in the 1990's"}, {'name': 'Cardiovascular disease', 'type': 'OTHER', 'description': "Cardiovascular disease - selfreported in the 1990's"}, {'name': 'Anthropometric measures', 'type': 'OTHER', 'description': 'Height, length, BMI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20501', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Lund University / Skane university hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Skane', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}