Bindex for Osteoporosis Diagnostics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bindex for Osteoporosis Diagnostics

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Diagnostic Test: Bindex measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for all: Postmenopausal status Age at 50 years or over Caucasian or Hispanic race (number shall be controlled, 140 in each group) Body mass index (BMI < 35) Additional criteria for Osteoporotic group - T-Score (NHANES database) -2.5 or lower at femoral neck or total femur Additional criteria for non-osteoporotic group - T-Score (NHANES database) > -2.5 at femoral neck or total femur Exclusion Criteria: for non-osteoporotic groups (Hispanic or Caucasian) Previous osteoporosis diagnosis Previous or current use of anti-fracture medication

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caucasian female<br> | Diagnostic Test: Bindex measurement<br>* One time bone density measurement with ultrasound device<br>|
| Hispanic female<br> | Diagnostic Test: Bindex measurement<br>* One time bone density measurement with ultrasound device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of DI | Sensitivity and specificity of DI in caucasian and hispanic groups | 3/11/2019-11/29/2019 |