Observational Study for the Assessment of Bone Mineral Density Using REMS Technology in Children and Adolescents

What this Trial Is About

This research aims to evaluate bone mineral density (BMD) in children and adolescents aged 5 to 18 years who have conditions that can negatively affect bone health. The study focuses on using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology, to measure BMD. This method is being studied as an alternative to DXA, the current standard, which has limitations in children due to radiation exposure and growth-related measurement issues. The trial is a national, single-center, non-profit interventional study lasting about 12 months. Participants will undergo BMD measurement using REMS technology along with collection of clinical history and assessment of body measurements and pubertal development. When available, previous DXA scan data will also be reviewed. The study plans to include approximately 100 patients. Analysis will describe BMD values measured by REMS in pediatric osteoporosis, explore differences in subgroups, and compare REMS results with DXA using statistical methods such as correlation coefficients and Bland-Altman analysis. During the study, participants will have BMD assessed at enrollment using REMS. Clinical and anthropometric data will be collected to understand their bone health status. The primary outcome measured is BMD in primary osteoporosis at enrollment. Secondary outcomes include BMD measurements in pediatric patients with various conditions affecting bone health. This observational approach will help assess the agreement between REMS and DXA, aiming to support REMS as a useful tool for pediatric bone health assessment.

REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)