Introduction: Dual X-Ray Absorptiometry (DXA) is the gold standard for the diagnosis of osteoporosis, but it has its pitfalls. The OsteoSee @Clinic is a novel portable and user-friendly system, which uses parametric Electrical Impedance Tomography (pEIT), being developed to allow screening and diagnosis of osteoporosis at the primary care clinic
Methods and Subjects: This prospective study was conducted between 01/01/2019 and 01/06/2019. Subjects who presented for a routine DXA scan (lumbar spine and proximal femur with Lunar Prodigy GE healthcare system) were enrolled. After signing an informed consent form, they were scanned with the OsteoSee @Clinic system (OsteoSee Ltd., Israel) using 5 electrodes placed around the left distal forearm and around the pelvis.
Results: OsteoSee @Clinic data were compared to DXA total hip bone mineral density (BMD). Correlations were examined between pEIT-index of the pelvis versus DXA total hip BMD. Sensitivity and specificity were calculated according to the diagnosis obtained by DXA based on the total hip T-score. An analysis based on 182 subjects (35 healthy, 115 osteopenia, 32 osteoporosis) scanned on the wrist showed an R-value of 0.795 (p-value < 0.001) representing the correlation between the pEIT-wrist index and DXA results. From the ROC plot, we obtained a sensitivity of 84% and specificity of 71% to diagnose osteoporotic vs osteopenic & normal subjects, and a sensitivity of 82% and specificity of 86% for identifying osteopenic & osteoporotic vs normal subjects. An analysis of 98 subjects (17 healthy, 66 osteopenic, 15 osteoporosis) scanned on the pelvis showed an R-value of 0.740 (p-value < 0.001), representing the correlation between the pEIT-pelvis index and DXA BMD. From the ROC plot, we obtained a sensitivity of 80% and specificity of 81% to diagnose osteoporotic vs osteopenic & normal subjects, and a sensitivity of 70% and specificity of 76% for identifying osteopenic & osteoporotic Vs normal subjects.
Conclusions: The OsteoSee @Clinic system results correlate well with DXA measurements, especially when taking into account clinical interpolations. Sensitivity and specificity values indicate that the OsteoSee @Clinic system can provide screening and diagnosis of osteoporosis. With the DXA system being costly to operate and inaccessible to many patients, the OsteoSee @Clinic system may address the unmet need for diagnosing and treating osteoporosis, and offer an alternative for a broader screening of the population at risk of fractures.