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Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX

NCT01998737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1011

Last updated 2017-09-21

Study results available
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Summary

Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) 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.

In this study we aim to investigate the strength of Density Index (DI) for prediction of proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI for osteoporosis diagnostics by using the International Society for Clinical Densitometry guidelines. In addition we aim to investigate how many additional women would be identified for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to DXA.

The investigators will start and organize a multicenter study in 5 osteoporosis clinics in Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the FRAX questioinnaire will be asked from everybody attending the study.

Clinical hypotheses:

1. Cortical bone thickness is decreased in osteoporosis.
2. Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).
3. Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.
4. Fracture risk factors (FRAX) and point-of-care bone density measurement together have significantly higher sensitivity and specificity for osteoporosis/treatment decisions than one method alone.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Heikki Kröger, MD, PhD · Kuopio University Hospital

  • Janne P Karjalainen, PhD · Bone Index Finland Ltd

  • Ossi Riekkinen, PhD · Bone Index Finland Ltd

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Finland

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 NCT01998737 on ClinicalTrials.gov