Abstract
Summary
An innovative, non-ionizing technique to diagnose osteoporosis on lumbar spine and femoral neck was evaluated through a multicenter study involving 1914 women. The proposed method showed significant agreement with reference gold standard method and, therefore, a potential for early osteoporosis diagnoses and possibly improved patient management.
Introduction
To assess precision (i.e., short term intra-operator precision) and diagnostic accuracy of an innovative non-ionizing technique, REMS (Radiofrequency Echographic Multi Spectrometry), in comparison with the clinical gold standard reference DXA (dual X-ray absorptiometry), through an observational multicenter clinical study.
Methods
In a multicenter cross-sectional observational study, a total of 1914 postmenopausal women (51–70 years) underwent spinal (n = 1553) and/or femoral (n = 1637) DXA, according to their medical prescription, and echographic scan of the same anatomical sites performed with the REMS approach. All the medical reports (DXA and REMS) were carefully checked to identify possible errors that could have caused inaccurate measurements: erroneous REMS reports were excluded, whereas erroneous DXA reports were re-analyzed where possible and otherwise excluded before assessing REMS accuracy. REMS precision was independently assessed.
Results
In the spinal group, quality assessment on medical reports produced the exclusion of 280 patients because of REMS errors and 78 patients because of DXA errors, whereas 296 DXA reports were re-analyzed and corrected. Analogously, in the femoral group there were 205 exclusions for REMS errors, 59 exclusions for DXA errors, and 217 re-analyzed DXA reports. In the resulting dataset (n = 1195 for spine, n = 1373 for femur) REMS outcome showed a good agreement with DXA: the average difference in bone mineral density (BMD, bias ± 2SD) was −0.004 ± 0.088 g/cm2 for spine and − 0.006 ± 0.076 g/cm2 for femur. Linear regression showed also that the two methods were well correlated: standard error of the estimate (SEE) was 5.3% for spine and 5.8% for femur. REMS precision, expressed as RMS-CV, was 0.38% for spine and 0.32% for femur.
Conclusions
The REMS approach can be used for non-ionizing osteoporosis diagnosis directly on lumbar spine and femoral neck with a good level of accuracy and precision. However, a more rigorous operator training is needed to limit the erroneous acquisitions and to ensure the full clinical practicability.
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Acknowledgments
The authors thank Carla Signorini for her help and assistance in performing the DXA scans.
Funding
This work was partially funded by the National Research Council, Institute of Clinical Physiology, Lecce (Italy) within the project “Non-ionizing diagnoses in rheumatology—ECO MOC.”
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Marco Di Paola, Davide Gatti, Ombretta Viapiana, Luisella Cianferotti, Loredana Cavalli, Carla Caffarelli, Eugenio Quarta, Paola Pisani, Giuseppe Girasole, Andrea Giusti, Monica Manfredini, Giovanni Arioli, Marco Matucci Cerinic, Gerolamo Bianchi, Ranuccio Nuti, Stefano Gonnelli, Maria Luisa Brandi, Maurizio Muratore, and Maurizio Rossini have no conflicts of interests.
Francesco Conversano owns stocks of Echolight Spa.
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Di Paola, M., Gatti, D., Viapiana, O. et al. Radiofrequency echographic multispectrometry compared with dual X-ray absorptiometry for osteoporosis diagnosis on lumbar spine and femoral neck. Osteoporos Int 30, 391–402 (2019). https://doi.org/10.1007/s00198-018-4686-3
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DOI: https://doi.org/10.1007/s00198-018-4686-3