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Bindex for Osteoporosis Diagnostics

NCT03878732 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 293

Last updated 2020-05-01

No results posted yet for this study

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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DIAGNOSTIC_TEST

Bindex measurement

One time bone density measurement with ultrasound device

Sponsors & Collaborators

  • New Mexico Clincial Research & Osteoporosis Center, Inc.

    collaborator UNKNOWN

  • Bone Index Finland Ltd

    lead INDUSTRY

Principal Investigators

  • Janne Karjalainen · Bone Index Finland Ltd

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2020-02-07
Completion
2020-02-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878732 on ClinicalTrials.gov