Scientific references

"Bindex® screening can be shown to be cost-effective compared to current practice."

Schousboe JT (2016) Prediction of hip osteoporosis by DXA using a novel pulse-echo ultrasound device, Osteoporosis International

Pulse-echo ultrasonometry can be used as a pre-screen for hip osteoporosis before dual-energy x-ray absorptiometry (DXA), potentially allowing DXA to be avoided for the majority of post-menopausal women. Pulse-echo ultrasound measures of tibia cortical thickness are also associated with radiographically confirmed prior fractures, independent of femoral neck bone mineral density.

Five hundred fifty-five post-menopausal women age 50 to 89 had femoral neck and total hip BMD measured by dual-energy x-ray absorptiometry (DXA), and pulse-echo ultrasound measures of distal radius, proximal tibia, distal tibia cortical thickness, and multi- and single-site density indices (DI). Using previously published threshold ultrasound values, we estimated the proportion of women who would avoid a follow-up DXA after pulse-echo ultrasonometry, and the sensitivity and specificity of this for the detection of hip osteoporosis. Logistic regression models were used to estimate the associations of pulse-echo ultrasound measures with radiographically confirmed clinical fractures within the prior 5years.

Using multi-site and single-site DI measures, follow-up DXA could be avoided for 73 and 69% of individuals, respectively, while detecting hip osteoporosis with 80-82% sensitivity and 81% specificity. Radiographically confirmed prior fracture was associated with ultrasound measures of single-site DI (odds ratio (OR) 1.55, 95% confidence interval (CI). 1.06 to 2.26) and proximal tibia cortical thickness (OR 1.47, 95% CI 1.10 to 1.96), adjusted for age, body mass index, and femoral neck BMD.

Pulse-echo ultrasonometry can be used as an initial screening test for hip osteoporosis. Prospective studies of how well pulse-echo ultrasound measures predict subsequent clinical fractures are warranted.

http://www.ncbi.nlm.nih.gov/pubmed/27492435

Karjalainen JP (2015) New Method for Point-of-care Osteoporosis Screening and Diagnostics, Osteoporosis International

Due to the lack of diagnostics in primary health care, over 75% of osteoporotic patients are not diagnosed. A new ultrasound method for primary health care is proposed. Results suggest applicability of ultrasound method for osteoporosis diagnostics at primary health care.

A total of 572 Caucasian women (age 20 to 91years) were examined using pulse-echo US measurements in the tibia and radius. This method provides an estimate of bone mineral density (BMD), i.e. density index (DI). Areal BMD measurements at the femoral neck (BMDneck) and total hip (BMDtotal) were determined by using axial dual-energy X-ray absorptiometry (DXA) for women older than 50years of age (n = 445, age = 68.8 ± 8.5years). The osteoporosis thresholds for the DI were determined according to the International Society for Clinical Densitometry (ISCD). Finally, the FRAX questionnaire was completed by 425 participants.

Osteoporosis was diagnosed in individuals with a T-score -2.5 or less in the total hip or femoral neck (n = 75). By using the ISCD approach for the DI, only 28.7% of the subjects were found to require an additional DXA measurement. Our results suggest that combination of US measurement and FRAX in osteoporosis management pathways would decrease the number of DXA measurements to 16% and the same treatment decisions would be reached at 85.4% sensitivity and 78.5% specificity levels.

The present results demonstrate a significant correlation between the ultrasound and DXA measurements at the proximal femur. The thresholds presented here with the application to current osteoporosis management pathways show promise for the technique to significantly decrease the amount of DXA referrals and increase diagnostic coverage; however, these results need to be confirmed in future studies.

http://www.ncbi.nlm.nih.gov/pubmed/26556741

Karjalainen JP (2015) Bindex® Technology for Osteoporosis Diagnostics in Primary Care, IOF-ECCEO Milan

A new ultrasound based point of care device (Bindex®) has been recently introduced for osteoporosis screening and diagnostics at primary healthcare. Thresholds (90% sensitivity and specificity, triage approach) for Density Index in osteoporosis assessment have been determined in Finnish Caucasian population along the International Society of Clinical Densitometry (ISCD) guidelines. In this multicentral study, these thresholds are tested in 9 research sites in US and Finland (n = 1316).

A total of 70% of the subjects could be directly diagnosed by using Bindex® measurement. Sensitivity and specificity in osteoporosis diagnostics was 89% and 90%, respectively.

Conclusion

These results suggest that Bindex® is suitable for osteoporosis screening and diagnostics in primary healthcare.

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Karjalainen JP (2014) Osteoporosis treatment decisions based on combining Bindex® and FRAX®, ASBMR Annual Meeting.

In this study, Bindex®, and FRAX® with BMI is used in treatment pathway analysis and compared to National Osteoporosis Foundation (NOF) and National Osteoporosis Guideline Group (NOGG) guidelines.

According to the proposed diagnostic pathway for USA (Bindex® + FRAX® with BMI), the sensitivity and specificity of treatment decisions were 94% and 80%, respectively, compared to the NOF guideline.

Conclusion

The present results demonstrate that the ultra-portable US instrument with FRAXBMI shows strong agreement (85% and 86%) with treatment decisions using NOGG and NOF guidelines. Further, the number of DXA measurements would decrease 53% - 77%.

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Karjalainen JP (2014) Bindex® Technology for Osteoporosis Diagnostics in US Primary Care, ASBMR Annual Meeting.

Bindex measures cortical thickness and determines parameter called density index (DI). Thresholds for DI in assessment of osteoporosis have been determined in Finnish Caucasian population along the International Society of Clinical Densitometry (ISCD) guidelines. In this study, these thresholds are tested in American-Caucasian population.

A total of 69.4% of the subjects could be directly diagnosed by using Bindex® measurement.

Conclusion

These results suggest that Finnish-Caucasian thresholds perform well in American-Caucasian population for detection of osteoporosis.

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Karjalainen JP (2013) Combination of pocket size ultrasound instrument and fracture probability tool for osteoporosis screening and diagnostics, IOF-ECCEO.

In this study, Bindex® is validated by using International Society for Clinical Densitometry (ISCD) guidelines for osteoporosis diagnostics.

By using ISCD approach for Bindex® , only 32.6% of the patients under osteoporosis suspicion were found to require additional DXA measurement to verify the osteoporosis diagnosis.

Conclusion

By using the ISCD approach and Bindex® technology with no ionizing radiation the treatment of osteoporosis would significantly increase.

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Asseburg C. (2013) Cost-effectiveness of pulse-echo ultrasound measurement of bone mineral density as a tool for osteoporosis screening and diagnostics, IOF-ECCEO.

In this study, Bindex® is compared to axial DXA in terms of health economic efficiency (incremental cost-effectiveness).

The average screening cost saved with Bindex® technique is 230€.

Conclusion

If Bindex® screening were included in the Finnish care pathway, costs would be saved compared to the current pathway. Moreover, Bindex® screening can be shown to be cost-effective compared to current practice.

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