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

February 13, 2026 updated by: Stefano Stagi, Meyer Children's Hospital IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Tuscany
      • Florence, Tuscany, Italy, 50100
        • Recruiting
        • AOU IRCCS Meyer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Age below 5 years or over 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic Test
Diagnostic test: REMS
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMD values in primary osteoporosis
Time Frame: At the enrollement
Mean and median of Bone Mineral Density values obtained in the pediatric population affected by primary osteoporosis
At the enrollement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMD values in pediatric patients with conditions negatively affecting bone health
Time Frame: At the enrollement
Mean and median of Bone Mineral Density values in pediatric patients with conditions negatively affecting bone health
At the enrollement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 7, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMS25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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