A portable real-time ultrasonic bone densitometer.

The objectives of this study were to develop a novel ultrasound device to estimate bone mineral density (BMD) at the calcaneus. The device is entirely self-contained, portable (<or=1 kg) and handheld and permits real-time evaluation of the BMD by computing a parameter known as net time delay (NTD). The NTD is defined as the difference between the transit time through the heel of an ultrasound signal and the transit time through a hypothetical object of equal thickness (to the heel) but containing soft tissue only. This parameter is sensitive primarily to the total amount (i.e., the average total thickness) of bone contained in the propagation path, and thus is equivalent to the bone mineral content estimated by dual-energy X-ray absorptiometry (DXA) scanners, and to the (areal) BMD when normalized by transducer area. Computer simulations of ultrasound propagation were used to study the relationship between NTD and BMD. The simulations used micro-computed tomography (micro-CT) images of a set of 10 calcaneal bone cores, which were further processed by morphologic image processing to obtain a set of 30 "samples" with BMDs ranging from 0.25 to 1.83 g/cm2. The NTD and BMD were found to be very highly correlated (r=0.99), demonstrating the high sensitivity of NTD to bone mass. A clinical institutional review board-approved study measured 85 adult women at the heel. BMD was measured at the same time using DXA. A linear regression using NTD produced a linear correlation coefficient of 0.86, which represents a significant improvement over present ultrasound bone densitometers, but not nearly as good as the simulation results. Reasons for this have been identified (viz., errors in distance measurement and lack of coincidence between the DXA and ultrasound regions of interest), and a new device and experimental protocol to deal with these sources of error has been developed and is currently under clinical trials. It is expected that this should improve the correlation between NTD and BMD even further (>or=0.9), effectively making the former parameter a proxy for the latter. In conclusion, although X-ray methods are effective in bone mass assessment, osteoporosis remains one of the largest undiagnosed and under-diagnosed diseases in the world today. The research described here, in conjunction with the fact that the devices are designed to be manufactured at very low cost (approximately $400 USD), should enable the significant expansion of diagnosis and monitoring of osteoporosis.