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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03878732
Other study ID # Bind2301
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 11, 2019
Est. completion date February 7, 2020

Study information

Verified date April 2020
Source Bone Index Finland Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 293
Est. completion date February 7, 2020
Est. primary completion date February 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Bindex measurement
One time bone density measurement with ultrasound device

Locations

Country Name City State
United States New Mexico Clincial Research & Osteoporosis Center, Inc. Albuquerque New Mexico

Sponsors (2)

Lead Sponsor Collaborator
Bone Index Finland Ltd New Mexico Clincial Research & Osteoporosis Center, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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