Application of the dual-frequency ultrasonometer for osteoporosis detection.

The paper presents results of a clinical validation study of Bone UltraSonic Scanner (BUSS), a novel dual-frequency axial transmission ultrasonometer, developed by Artann Laboratories. Assessment of bone conditions is based on evaluating relative changes of the axial profiles of ultrasonic characteristics in long bones and utilizes bulk and guided acoustic waves. The objective of this study was to determine the ability of BUSS to discriminate osteoporosis development stages. A total of 93 menopausal and post-menopausal women divided into five groups from normal to advanced osteoporosis according to their DXA hip t-score were enrolled in the study. The 2D waveform profiles at low (0.1 MHz) and high (1 MHz) frequencies were obtained by scanning 15 cm along the proximal tibia. A multi-parametric linear classifier based on a set of the parameters derived from 2D acoustic waveform profiles has been developed. The efficiency of this classifier in differentiating osteoporosis from a normal sample was assessed using a receiver operating characteristic (ROC) curve analysis. Based on the ROC analysis, BUSS demonstrated 76% sensitivity and 70% specificity to DXA-identified osteoporosis. The area under the ROC curve, which is a measure of how well a parameter can distinguish between the two diagnostic groups (diseased/normal) was 79.3%. The study confirmed BUSS's capability to discriminate between stages of bone atrophy and in particular to distinguish early changes induced by osteoporosis.