Bindex for Osteoporosis Diagnostics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis, Postmenopausal
- Sponsor
- Bone Index Finland Ltd
- Enrollment
- 293
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity of DI
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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. Application 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. This 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •for non-osteoporotic groups (Hispanic or Caucasian)
- •Previous osteoporosis diagnosis
- •Previous or current use of anti-fracture medication
Outcomes
Primary Outcomes
Sensitivity and specificity of DI
Time Frame: 3/11/2019-11/29/2019
Sensitivity and specificity of DI in caucasian and hispanic groups