NCT07143552 Bone Outcomes, Obesity, Sunlight, and Trauma in Children
| NCT ID | NCT07143552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Paracelsus Medical University |
| Condition | Pediatric Fractures |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-07-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Andrea Cosentino, MD
PRINCIPAL INVESTIGATOR
Franz Tappeiner Hospital; Paracelsus Medical University
Frequently Asked Questions
Who can join the NCT07143552 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 15 Years, studying Pediatric Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07143552 currently recruiting?
Yes, NCT07143552 is actively recruiting participants. Contact the research team at andrea.cosentino@stud.pmu.ac.at for enrollment information.
Where is the NCT07143552 trial being conducted?
This trial is being conducted at Brixen, Italy, Meran, Italy.
Who is sponsoring the NCT07143552 clinical trial?
NCT07143552 is sponsored by Paracelsus Medical University. The principal investigator is Andrea Cosentino, MD at Franz Tappeiner Hospital; Paracelsus Medical University. The trial plans to enroll 100 participants.