NCT07412782 REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)
| NCT ID | NCT07412782 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meyer Children's Hospital IRCCS |
| Condition | Osteogenesis Imperfecta |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-04 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07412782 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Osteogenesis Imperfecta. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07412782 currently recruiting?
Yes, NCT07412782 is actively recruiting participants. Contact the research team at stefano.stagi@unifi.it for enrollment information.
Where is the NCT07412782 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT07412782 clinical trial?
NCT07412782 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 100 participants.