Bindex for Osteoporosis Diagnostics

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Diagnostic Test: Bindex measurement

• Registration Number: NCT03878732
• Lead Sponsor: Bone Index Finland Ltd

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.

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Primary Completion: 2020-02-07
• Study Completion: 2020-02-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 293

Inclusion Criteria

Not provided

Exclusion Criteria

for non-osteoporotic groups (Hispanic or Caucasian)

• Previous osteoporosis diagnosis
• Previous or current use of anti-fracture medication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hispanic female	Bindex measurement	-
Caucasian female	Bindex measurement	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of DI	3/11/2019-11/29/2019	Sensitivity and specificity of DI in caucasian and hispanic groups

Trial Locations

Locations (1)

New Mexico Clincial Research & Osteoporosis Center, Inc.; 🇺🇸 Albuquerque, New Mexico, United States