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Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer

NCT01978834 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 560

Last updated 2015-01-29

No results posted yet for this study

Summary

This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.

First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.

1. To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.

Conditions

Sponsors & Collaborators

  • HealthPartners Institute

    collaborator OTHER

  • Bone Index Finland Ltd

    lead INDUSTRY

Principal Investigators

  • John T Schousboe, MD, PhD · HealthPartners Institute

  • Janne P Karjalainen, PhD · Bone Index Finland Ltd

  • Ossi Riekkinen, PhD · Bone Index Finland Ltd

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01978834 on ClinicalTrials.gov