Using REMS ultrasound to check bone density in children and teens with conditions that lower bone strength
Observational Study for the Assessment of Bone Mineral Density (BMD) Using REMS Technology
This project will test whether REMS, a radiation-free ultrasound method, can measure bone mineral density in children and adolescents aged 5–18 who have conditions that weaken their bones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Florence, Tuscany) |
| Trial ID | NCT07412782 on ClinicalTrials.gov |
What this trial studies
Researchers at Meyer Children's Hospital will enroll children and adolescents aged 5–18 with conditions known to impair bone health and perform REMS (Radiofrequency Echographic Multi Spectrometry) scans to obtain bone mineral density measurements. Participants will have clinical history recorded and undergo anthropometric and pubertal assessments, with prior DXA results collected when available. The single-center, non-profit interventional protocol will run about 12 months and uses a non-invasive, radiation-free ultrasound approach. The primary aim is to describe REMS-derived BMD values in pediatric patients with osteoporosis-related conditions and generate preliminary pediatric data.
Who should consider this trial
Good fit: Children and adolescents aged 5–18 with a documented condition that negatively affects bone health who can provide consent/assent with parental permission are ideal candidates.
Not a fit: Children under 5 or over 18, those without bone-impacting conditions, or patients who require DXA-based results for immediate clinical decisions may not receive benefit from this protocol.
Why it matters
Potential benefit: If successful, REMS could provide a safe, radiation-free way to monitor bone density in children and reduce dependence on DXA.
How similar studies have performed: REMS has been validated for bone density measurement in adults and early pediatric reports are promising, but standardized pediatric reference values are not yet established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Florence, Tuscany
- AOU IRCCS Meyer — Florence, Tuscany, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Stagi, Professor
- Email: stefano.stagi@unifi.it
- Phone: 0039 0555662305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.