Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 8:48 PM
Study NCT ID:
NCT03895333
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing Loss and Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'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': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-25', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hearing test results', 'timeFrame': '1 week', 'description': 'hearing test results will be examined; Hearing loss result: test passed or test will be recorded as not passed.'}, {'measure': 'bone mineral densitometry measurements', 'timeFrame': '1 week', 'description': 'bone mineral densitometry measurements of patients with hearing test. those with bone loss will be evaluated as osteoporosis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone mineral density', 'Postmenopause'], 'conditions': ['Hearing Loss', 'Osteoporosis, Postmenopausal']}, 'descriptionModule': {'briefSummary': 'To compare the audiological profiles in postmenopausal women with and without osteoporosis and to examine the pattern of hearing loss in osteoporotic patients. postmenopausal women will be separated as normal, osteopenic and osteoporotic according to bone mineral densitometry results. The evaluation of hearing test will be done in these groups and the results will be compared between the groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women who had hearing test between the ages of 45-60 formed the study group', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 45-60 years\n* postmenopausal women\n\nExclusion Criteria:\n\n* Women over 60 years old,\n* acute or chronic otitis media,\n* ear surgery,\n* use of ototoxic drugs,\n* congenital hearing loss,\n* previous long-term steroid use,\n* malignant or benign neoplasm of the brain,\n* Patients with a history of exposure to noise were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03895333', 'briefTitle': 'Hearing Loss and Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Audiological Profiling in Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': '2019.01.01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'women with hearing loss and osteoporosis will develop the study group.', 'interventionNames': ['Other: Audiological profiling and bone mineral densitometry measurement']}, {'label': 'control group', 'description': 'women who have hearing loss but have no osteoporosis will constitute the control group.', 'interventionNames': ['Other: Audiological profiling and bone mineral densitometry measurement']}], 'interventions': [{'name': 'Audiological profiling and bone mineral densitometry measurement', 'type': 'OTHER', 'description': 'bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33404', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, M.D, Department of Obstetrics and GynecologyR', 'investigatorFullName': 'Pınar Kadirogulları', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}