RecruitingNot Applicable

Bone Outcomes, Obesity, Sunlight, and Trauma in Children

Italy100 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range3 Years – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Serum 25-hydroxyvitamin D (nmol/L)

Timeframe: within 7 days

BMI

Timeframe: at baseline

Trial details

NCT IDNCT07143552

SponsorParacelsus Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01

Contact for this trial

Andrea Cosentino, MD

+393334503625 andrea.cosentino@stud.pmu.ac.at

View on ClinicalTrials.gov More Pediatric Fractures trials