Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-08 @ 7:48 AM
Study NCT ID:
NCT02771834
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postural balance', 'timeFrame': '1 day', 'description': 'Was evaluated using a AccuSway® model portable force platform, in standard standing position, with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.'}, {'measure': 'Muscle strength', 'timeFrame': '1 day', 'description': 'Was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.'}, {'measure': 'Vitamin D level', 'timeFrame': '1 day', 'description': 'Dosing of 25 OH vitamin D in a blood test'}, {'measure': 'Degree of kyphosis', 'timeFrame': '1 day', 'description': 'Thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group'}], 'primaryOutcomes': [{'measure': 'International Physical Activity Questionnaire', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Functional mobility', 'timeFrame': '1 day', 'description': 'Was evaluated through the Timed Up and Go Test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postural balance', 'Osteoporosis', 'Postmenopause', 'Vitamin D', 'Kyfhosis', 'Muscle strength'], 'conditions': ['Postural Balance']}, 'referencesModule': {'references': [{'pmid': '28226027', 'type': 'DERIVED', 'citation': 'Brech GC, Ciolac EG, Peterson MD, Greve JM. Serum 25-hydroxyvitamin D levels are associated with functional capacity but not with postural balance in osteoporotic postmenopausal women. Clinics (Sao Paulo). 2017 Jan 1;72(1):11-16. doi: 10.6061/clinics/2017(01)03.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of osteoporosis has been increasing, as have fractures resulting from falls.', 'detailedDescription': 'The overall objective of this study is to evaluate bipodal postural balance in postmenopausal women with and without lumbar osteoporosis. The specific objective is to determine the relationship between the degree of thoracic kyphosis and dosing of 25 OH vitamin D with postural balance in postmenopausal women with lumbar osteoporosis.\n\nOne hundred and twenty-six postmenopausal women between 55-65 years of age were evaluated and separated into two groups according to the bone mineral density values of their lumbar spine: the osteoporosis group and the control group.\n\nFunctional mobility was evaluated through the Timed Up and Go Test. Postural balance was evaluated using a AccuSway® model portable force platform, in standard standing position, with eyes open and closed, for 60". Data were collected, stored, and processed by the Balance Clinic® program, configured to 100 Hz frequency, with a frequency cut-off filter at 10 Hz.\n\nMuscle strength was evaluated via a Biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s.\n\nDosing of 25 OH vitamin D and thoracic spine x-rays to determine the degree of kyphosis measured by the Cobb angle were performed in the osteoporosis group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* absence of impairment of the vestibular, proprioceptive, auditory or neurological system, and/or any mental disturbances or disorders;\n* no use of medications that might compromise postural balance;\n* absence of lesions, surgery or disease that might have caused lower-limb joint limitations over the previous six months;\n* absence of lower-limb dysmetria;\n* presence of clinically normal gait, without claudication.\n\nExclusion Criteria:\n\n* the presence of pain or inability to complete any of the tests\n* along with occurrences of blood pressure increase before the strength evaluation.'}, 'identificationModule': {'nctId': 'NCT02771834', 'briefTitle': 'Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Evaluation of the Association Between Osteoporosis and Postural Balance in Postmenopausal Women', 'orgStudyIdInfo': {'id': '320/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'women with osteoporosis', 'interventionNames': ['Other: Biomechanical analysis', 'Other: Kiphosis analysis', 'Other: Vitamin D level']}, {'label': 'Control', 'description': 'women without osteoporosis', 'interventionNames': ['Other: Biomechanical analysis']}], 'interventions': [{'name': 'Biomechanical analysis', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Experimental']}, {'name': 'Kiphosis analysis', 'type': 'OTHER', 'armGroupLabels': ['Experimental']}, {'name': 'Vitamin D level', 'type': 'OTHER', 'armGroupLabels': ['Experimental']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd', 'investigatorFullName': 'Guilherme Carlos Brech', 'investigatorAffiliation': 'University of Sao Paulo'}}}}