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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Test | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At the enrollement |
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Inclusion Criteria:
Exclusion Criteria:
- Age below 5 years or over 18 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Stagi, Professor | Contact | 0039 0555662305 | stefano.stagi@unifi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU IRCCS Meyer | Recruiting | Florence | Tuscany | 50100 | Italy |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| D010024 | Osteoporosis |
| D009369 | Neoplasms |
| D009765 | Obesity |
| D050177 | Overweight |
| D044342 | Malnutrition |
| D003480 | Cushing Syndrome |
| D004393 | Dwarfism, Pituitary |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D004392 | Dwarfism |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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