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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorMeyer Children's Hospital IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • REMS

    Diagnostic test

    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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Diagnostic TestExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

BMD values in primary osteoporosis

Mean and median of Bone Mineral Density values obtained in the pediatric population affected by primary osteoporosis

Time frame
At the enrollement

Secondary outcomes

1

BMD values in pediatric patients with conditions negatively affecting bone health

Mean and median of Bone Mineral Density values in pediatric patients with conditions negatively affecting bone health

Time frame
At the enrollement

Other outcomes

Sponsors and contacts

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