RecruitingNot ApplicableNCT07412782

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

Observational Study for the Assessment of Bone Mineral Density (BMD) Using REMS Technology


Sponsor

Meyer Children's Hospital IRCCS

Enrollment

100 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Bone health is crucial during childhood, when peak bone mass develops, and reduced BMD is associated with increased fracture risk. DXA is the current reference method but has limitations in children, including radiation exposure and growth-related measurement issues. REMS has been validated in adults and shows promise in pediatrics, despite the lack of reference values. The study is a single-center, national, non-profit interventional study lasting about 12 months. Participants will undergo REMS BMD measurement, clinical history collection, and assessment of anthropometric and pubertal parameters, with prior DXA data collected when available. The primary aim is to describe BMD values measured by REMS in pediatric osteoporosis, with secondary aims including subgroup analyses and comparison with DXA. A sample of 100 patients is planned. Statistical analyses will assess BMD distributions, correlations with clinical variables, and agreement between REMS and DXA using correlation coefficients and Bland-Altman analysis.


Eligibility

Min Age: 5 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a non-invasive ultrasound-based technology called REMS (radiofrequency echographic multi spectrometry) to measure bone density in children and teenagers with conditions that are known to negatively affect bone health — as an alternative or complement to standard bone scans. **You may be eligible if...** - You are between 5 and 18 years old - You have a known medical condition that affects bone health (for example: chronic illness, long-term steroid use, endocrine conditions, or nutritional deficiencies) - A parent or legal guardian has provided written consent **You may NOT be eligible if...** - You are younger than 5 or older than 18 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTREMS

REMS (Radiofrequency Echographic Multi Spectrometry) technology, a non-invasive, radiation-free ultrasound system to detect BMD. REMS has obtained FDA and CE approval and has been validated


Locations(1)

AOU IRCCS Meyer

Florence, Tuscany, Italy

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NCT07412782


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