Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT05823558
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2023-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Lumbar Muscle Thickness Measurements in Osteoporotic and Osteopenic Patients
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 301}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2023-04-10', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lomber Muscle Measurement', 'timeFrame': 'Day 1', 'description': 'Psoas and multifidus muscle measurements will be made at L2-L3 level in Lumbar MR imaging.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'In osteoporosis, sarcopenia is a common condition. Sarcopenic measurements can be made by evaluating muscle thickness in different regions. We aim to evaluate lumbar muscle losses in patients with osteoporosis in the lumbar region and to examine whether these muscle losses are correlated with the level of osteoporosis. The patients will be divided into 3 groups as healthy, osteopenic and osteoporotic according to DEXA measurements. Demographic values, comorbidities, osteoporosis drugs used, fracture histories, L1-4, L2-4, femoral neck and total BMD and t values of the patients, psoas and multifidus muscle measurements will be made at L2-L3 level in Lumbar MR imaging. Lumbar MR muscle measurements will be made by 1 physician blind to the DEXA values of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '50-90 years old osteoporotic, osteopenic and healthy people', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50-90 years old\n* 2\\. Recent MRI of the lumbar region with DEXA evaluation\n\nExclusion Criteria:\n\n* Have had previous lumbar surgery\n* Any previous lumbar injection\n* Stage 3-4 Lumbar Listesis\n* Presence of Lumbar Discopathy accompanied by neurological deficit'}, 'identificationModule': {'nctId': 'NCT05823558', 'briefTitle': 'Comparison of Lumbar Muscle Thickness Measurements in Osteoporotic and Osteopenic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'Comparison of Lumbar Muscle Thickness Measurements in Osteoporotic and Osteopenic Patients', 'orgStudyIdInfo': {'id': '10042023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ostoporotic Patients Group', 'description': 'T value of -2.5 and below in DEXA measurement', 'interventionNames': ['Diagnostic Test: Lomber Muscle Thickness Measurement']}, {'label': 'Osteopenic Patients Group', 'description': 'T value between -2.5 and -1 in DEXA measurement', 'interventionNames': ['Diagnostic Test: Lomber Muscle Thickness Measurement']}, {'label': 'Healthy Group', 'description': 'T value of -1 and above in DEXA measurement', 'interventionNames': ['Diagnostic Test: Lomber Muscle Thickness Measurement']}], 'interventions': [{'name': 'Lomber Muscle Thickness Measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Muscle thickness measurements will be made on the imaging of those who have lumbar MR imaging.', 'armGroupLabels': ['Healthy Group', 'Osteopenic Patients Group', 'Ostoporotic Patients Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34100', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Etfal Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Aylin Ayyıldız', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}