Clinical Trials Directory

Trials / Completed

CompletedNCT03878732

Bindex for Osteoporosis Diagnostics

Status
Completed
Phase
—
Study type
Observational
Enrollment
293 (actual)
Sponsor
Bone Index Finland Ltd · Industry
Sex
Female
Age
50 Years – 100 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBindex measurementOne time bone density measurement with ultrasound device

Timeline

Start date
2019-03-11
Primary completion
2020-02-07
Completion
2020-02-07
First posted
2019-03-18
Last updated
2020-05-01

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03878732. Inclusion in this directory is not an endorsement.