Bone Outcomes, Obesity, Sunlight, and Trauma in Children
Recruiting · NCT07143552 · Observational (researchers observe without assigning treatment) · Lead sponsor: Paracelsus Medical University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
3 Years to 15 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed.
- Kaiser Franz Joseph Hospital - Brixen, Bolzano, Italy
- Franz Tappeiner Hospital - Meran, Bolzano, Italy