Bone health, vitamin D, weight, and fractures in children
Official title: A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
Run by Paracelsus Medical University · NCT07143552 · Data updated 2026-11-12
See if blood markers (alkaline phosphatase, calcium, PTH, vitamin D), body weight, and calcium intake are linked to fractures in children aged 3–15 after low-energy trauma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 15 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Paracelsus Medical University Academic / other |
| Locations | 2 sites (Brixen, Bolzano and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | January 2026 |
| Study ends | September 2026 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT07143552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3–15 presenting after low-energy trauma who either have a radiographic fracture (cases) or comparable trauma without fracture (controls) are ideal candidates.
✕Probably not a fit
Children with chronic renal or liver disease, primary parathyroid disorders, hypophosphatemic rickets, neuromuscular disorders, current corticosteroid or bisphosphonate therapy, unclear diagnoses, or those with high-energy injuries are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective case-control study enrolls children aged 3–15 who present after low-energy trauma and separates them into radiographically confirmed fracture cases and non-fracture controls. Within seven days of the injury, researchers collect non-fasting blood (kept on ice for PTH) to measure 25-hydroxyvitamin D, PTH, alkaline phosphatase, calcium, and phosphate, and record BMI percentile and dietary calcium intake. The primary analysis tests the association of serum alkaline phosphatase and calcium with fracture status, while secondary analyses examine vitamin D status, BMI percentile, and a composite Bone Risk Score (≥3). Group comparisons, logistic regression, and ROC analyses will be used to identify markers associated with fracture risk.
Why it matters
Potential benefit: Could help identify children at higher risk of skeletal fragility so clinicians can target prevention such as vitamin D or calcium supplementation and weight-management strategies.
How similar studies have gone: Previous pediatric and adult observational studies have linked vitamin D deficiency, altered bone markers, and obesity to higher fracture risk, but combined pediatric case-control analyses addressing all these factors are relatively limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 3-15 years; * low-energy trauma; * cases = radiographic fracture; controls = no fracture. Exclusion Criteria: * chronic renal/liver disease; * primary hypo-/hyperparathyroidism; * hypophosphatemic rickets; * neuromuscular disorders; * corticosteroids/bisphosphonates; * unclear diagnosis/treatment.
Where it's running
-
Kaiser Franz Joseph Hospital
Brixen, Bolzano, Italy Recruiting -
Franz Tappeiner Hospital
Meran, Bolzano, Italy Recruiting
Study contacts
- Principal investigator: Andrea Cosentino, MD — Franz Tappeiner Hospital; Paracelsus Medical University
- Study coordinator: Andrea Cosentino, MD
- Email: andrea.cosentino@stud.pmu.ac.at
- Phone: +393334503625
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.