Bindex for Osteoporosis Diagnostics

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Diagnostic test: Bindex measurement

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 Type: Observational
• Enrollment (Actual): 293

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clincial Research & Osteoporosis Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Random sample of eligible female subjects who are being treated at collaborating clinic.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Caucasian female	Diagnostic test: Bindex measurement; One time bone density measurement with ultrasound device
Hispanic female	Diagnostic test: Bindex measurement; One time bone density measurement with ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bone Index Finland Ltd
• Collaborators: New Mexico Clincial Research & Osteoporosis Center, Inc.
• Investigators: Study Chair: Janne Karjalainen, Bone Index Finland Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: Bind2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No