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| Name | Class |
|---|---|
| New Mexico Clincial Research & Osteoporosis Center, Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caucasian female |
| ||
| Hispanic female |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bindex measurement | Diagnostic Test | One time bone density measurement with ultrasound device |
|
| 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 |
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Inclusion Criteria for all:
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)
Review history. No genetic testing shall be done or confirmation of external sexual organs.Transgender individuals will not be included in the study population.
Random sample of eligible female subjects who are being treated at collaborating clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Janne Karjalainen | Bone Index Finland Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Mexico Clincial Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | United States |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |