A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY
Prospective case-control study of children (3-15 years) after low-energy trauma. We compare serum bone metabolic markers (25OHD, PTH, ALP, calcium, phosphate), BMI/percentile, and dietary calcium intake between fracture and non-fracture presentations. Blood is collected within 7 days (non-fasting; samples on ice for PTH). Primary aim: association of ALP and calcium with fracture status; secondary aims: vitamin D status, BMI percentile, and a composite Bone Risk Score (≥3). Analyses: group comparisons, logistic regression, ROC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 15
Healthy Volunteers: t
View:
• 3-15 years;
• low-energy trauma;
• cases = radiographic fracture; controls = no fracture.
Locations
Other Locations
Italy
Kaiser Franz Joseph Hospital
RECRUITING
Brixen
Franz Tappeiner Hospital
RECRUITING
Meran
Contact Information
Primary
Andrea Cosentino, MD
andrea.cosentino@stud.pmu.ac.at
+393334503625
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 100
Treatments
Fracture group
Children aged 3-15 years with radiologically confirmed low-energy fractures.
Control group
Children aged 3-15 years with low-energy trauma but no radiological evidence of fracture.
Related Therapeutic Areas
Sponsors
Leads: Paracelsus Medical University