Bone health status evaluation in men by means of REMS technology.

BACKGROUND: Osteoporosis in males is largely under-diagnosed and under-treated, with most of the diagnosis confirmed only after an osteoporotic fracture. Therefore, there is an urgent need for highly accurate and precise technologies capable of identifying osteoporosis earlier, thereby avoiding complications from fragility fractures. AIMS: This study aimed to evaluate the diagnostic accuracy and precision of the non-ionizing technology Radiofrequency Echographic Multi Spectrometry (REMS) for the diagnosis of osteoporosis in a male population in comparison with conventional Dual-energy X-ray Absorptiometry (DXA). METHODS: A cohort of 603 Caucasian males aged between 30 and 90 years were involved in the study. All the enrolled patients underwent lumbar and femoral scans with both DXA and REMS. The diagnostic agreement between REMS and DXA-measured BMD was expressed by Pearson correlation coefficient and Bland-Altman method. The accuracy of the diagnostic classification was evaluated by the assessment of sensitivity and specificity considering DXA as reference. RESULTS: A significant correlation between REMS- and DXA-measured T-score values (r = 0.91, p < 0.0001) for lumbar spine and for femoral neck (r = 0.90, p < 0.0001) documented the substantial equivalence of the two measurement techniques. Bland-Altman outcomes showed that the average difference in T-score measurement is very close to zero (-0.06 ± 0.60 g/cm2 for lumbar spine and - 0.07 ± 0.44 g/cm2 for femoral neck) confirming the agreement between the two techniques. Furthermore, REMS resulted an effective technique to discriminate osteoporotic patients from the non-osteoporotic ones on both lumbar spine (sensitivity = 90.1%, specificity = 93.6%) and femoral neck (sensitivity = 90.9%, specificity = 94.6%). Precision yielded RMS-CV = 0.40% for spine and RMS-CV = 0.34% for femur. CONCLUSION: REMS, is a reliable technology for the diagnosis of osteoporosis also in men. This evidence corroborates its high diagnostic performance already observed in previous studies involving female populations.

Product Registration in Developing Countries: A Proposal for an Integrated Regional Licensing System Among Countries in Regional Economic Blocs.

The product pipeline for diseases that disproportionately affect the developing world has considerably expanded over the last decade. Indeed, there are about 134 products for these diseases in the pipeline, including vaccines, drugs, diagnostics, microbicides, and vector control tools, and dozens of these products are currently being evaluated in human trials in developing countries where the disease of interest exists. While these efforts are underway, the need to identify regulatory pathways for licensing these new products is becoming obvious to many manufacturers. In many developing countries, where the need of these products is greatest, the national regulatory authorities often lack the resources and regulatory capacity to review the registration dossiers to approve the use of new products. Given this challenge, new regulatory models are urgently needed to offset product registration. In this paper, we propose how regional regulatory frameworks established by regional harmonization initiatives can be used to set up an integrated regional licensing system, a system that will provide for a single product dossier application and a single review, leading to a single approval that will grant access to all the markets in the region. The proposed model aims at complementing the ongoing regional regulatory harmonization efforts by pooling the activities of different national expertise groups so as to make the best use of the available skills at a reduced cost. By sharing the various regulatory tasks in an integrated manner, the total process will be accelerated and will facilitate product registration in the region.