Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-30 @ 10:36 AM
Study NCT ID:
NCT03878732
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2019-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bindex for Osteoporosis Diagnostics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2019-03-15', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of DI', 'timeFrame': '3/11/2019-11/29/2019', 'description': 'Sensitivity and specificity of DI in caucasian and hispanic groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal']}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition. Bindex ultrasound device has been developed and validated in Caucasian female population. In this study, diagnostic thresholds for density index as determined with Bindex will be evaluated in two different ethnic populations.', 'detailedDescription': 'Currently, the diagnosis of osteoporosis is based on the measurement of bone mineral density (BMD), using axial dual energy X-ray absorptiometry (DXA) of the hip and/or the lumbar spine at special healthcare.\n\nApplication of diagnostic thresholds determined against BMD have been suggested by International Society for Clinical Densitometry (ISCD) for use with peripheral bone densitometry devices (90% sensitivity and 90% specificity). These thresholds have been determined and validated for Bindex in Caucasian female population.\n\nThis study focuses on clinical validation of the ultrasound device (Bindex®, Bone Index Finland Ltd., www.boneindex.com) device and Density Index (DI), a diagnostic parameter reported by Bindex. The predetermined thresholds for DI will be evaluated by measuring 70 osteoporotic and 70 healthy patients with Bindex and DXA in each selected patient groups. The feasibility of DI for diagnostics of osteoporosis in these groups will be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Random sample of eligible female subjects who are being treated at collaborating clinic.', 'genderDescription': 'Review history. No genetic testing shall be done or confirmation of external sexual organs.Transgender individuals will not be included in the study population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for all:\n\n* Postmenopausal status\n* Age at 50 years or over\n* Caucasian or Hispanic race (number shall be controlled, 140 in each group)\n* Body mass index (BMI \\< 35)\n\nAdditional criteria for Osteoporotic group\n\n\\- T-Score (NHANES database) -2.5 or lower at femoral neck or total femur\n\nAdditional criteria for non-osteoporotic group\n\n\\- T-Score (NHANES database) \\> -2.5 at femoral neck or total femur\n\nExclusion Criteria:\n\nfor non-osteoporotic groups (Hispanic or Caucasian)\n\n* Previous osteoporosis diagnosis\n* Previous or current use of anti-fracture medication'}, 'identificationModule': {'nctId': 'NCT03878732', 'briefTitle': 'Bindex for Osteoporosis Diagnostics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bone Index Finland Ltd'}, 'officialTitle': 'Bindex for Osteoporosis Diagnostics', 'orgStudyIdInfo': {'id': 'Bind2301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caucasian female', 'interventionNames': ['Diagnostic Test: Bindex measurement']}, {'label': 'Hispanic female', 'interventionNames': ['Diagnostic Test: Bindex measurement']}], 'interventions': [{'name': 'Bindex measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'One time bone density measurement with ultrasound device', 'armGroupLabels': ['Caucasian female', 'Hispanic female']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Clincial Research & Osteoporosis Center, Inc.', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Janne Karjalainen', 'role': 'STUDY_CHAIR', 'affiliation': 'Bone Index Finland Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bone Index Finland Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'New Mexico Clincial Research & Osteoporosis Center, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}