Bone health, vitamin D, weight, and fractures in children
A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 15 Years |
| Sex | All |
| Sponsor | Paracelsus Medical University Academic / other |
| Locations | 2 sites (Brixen, Bolzano and 1 other locations) |
| Trial ID | NCT07143552 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brixen, Bolzano and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.