Bindex for Osteoporosis Diagnostics

Osteoporosis, Postmenopausal Clinical Trial

Official title:

Bindex for Osteoporosis Diagnostics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878732
• Other study ID #: Bind2301
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

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