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

NCT07412782 | Recruiting

• 1 other identifier: REMS25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteogenesis Imperfecta; Osteoporosis; Hypogonadisms; Neoplasia; Obesity & Overweight; Malnutrition (Calorie); Hypercortisolism; Growth Hormone Deficiency (GHD); Osteopenia

Outcome Measures

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

  At the enrollement

Secondary Outcomes (1)

• BMD values in pediatric patients with conditions negatively affecting bone health

  At the enrollement

Study Arms (1)

Diagnostic Test

EXPERIMENTAL

Diagnostic Test: REMS

Interventions

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

Diagnostic Test

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Age below 5 years or over 18 years

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

AOU IRCCS Meyer

Florence, Tuscany, 50100, Italy

RECRUITING

MeSH Terms

Conditions

Osteogenesis Imperfecta; Osteoporosis; Neoplasms; Obesity; Overweight; Malnutrition; Cushing Syndrome; Dwarfism, Pituitary; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Dwarfism; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Stefano Stagi, Professor

CONTACT

0039 0555662305; stefano.stagi@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 17, 2026
• Study Start: December 4, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)