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NCT Number: NCT07412782

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

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.

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Key information

Conditions

Osteogenesis Imperfecta Adrenal Gland Diseases Adrenocortical Hyperfunction Body Weight Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Bone Diseases, Metabolic Brain Diseases Central Nervous System Diseases Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cushing Syndrome Dwarfism Dwarfism, Pituitary Endocrine System Diseases Genetic Diseases, Inborn Growth Hormone Deficiency (GHD) Hypercortisolism Hypogonadisms Hypopituitarism Hypothalamic Diseases Malnutrition Malnutrition (Calorie) Metabolic Diseases Musculoskeletal Diseases Neoplasia Neoplasms Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Osteochondrodysplasias Osteopenia Osteoporosis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pituitary Diseases Signs and Symptoms Skin and Connective Tissue Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU IRCCS Meyer

Florence, Tuscany, 50100, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Stagi, Professor

CONTACT

[email protected]

0039 0555662305

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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