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NCT07412782Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
7 Feb 2026
Start date
4 Dec 2025
Primary completion date
15 Jun 2026
Lead sponsor
Meyer Children's Hospital IRCCS
NCT number
NCT07412782

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 4 Dec 2025 to the primary completion date, 15 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • \- Age below 5 years or over 18 years

Who the study is looking for

  • Written informed consent from adult patients or parents/legal guardians
  • Age between 5 and 18 years
  • Both sexes and all ethnicities
  • Known condition negatively affecting bone health

Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AOU IRCCS Meyer
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.