Obese adolescents have higher risk for severe lower extremity fractures after falling.
Nicolas Gonzalez, Jeffry Nahmias, Sebastian Schubl...
https://pubmed.ncbi.nlm.nih.gov/37466766Actively Recruiting
Age: 3Years - 15Years
All Genders
Healthy Volunteers
ID07143552
A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
Led by Paracelsus Medical University · Updated on 2025-09-03
100
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the relationship between vitamin D levels, bone metabolism, and obesity in children aged 3 to 15 years who have experienced low-energy trauma. The study compares children with confirmed fractures to those with similar trauma but no fractures to explore factors that may contribute to bone fragility and fracture risk. Participants are divided into two groups: children with radiologically confirmed low-energy fractures and children with low-energy trauma but no fractures. Blood samples are collected within seven days of trauma to measure markers such as 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase, calcium, and phosphate. Dietary calcium intake and body measurements are also recorded to evaluate nutritional and metabolic status. Children will undergo baseline assessments including body mass index measurement and a dietary questionnaire. Researchers analyze blood markers and calculate a composite bone risk score to identify factors linked to fracture risk. The study uses statistical methods to compare groups and assess the association between bone markers and fractures, aiming to improve understanding of pediatric bone health and inform prevention strategies.
CONDITIONS
Brief Title
Bone Outcomes, Obesity, Sunlight, and Trauma in Children
Who Can Participate
Age: 3Years - 15Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 3 and 15 years
- Recent low-energy trauma
- Cases must have radiographic confirmation of fracture
- Controls must have low-energy trauma without fracture
You will not qualify if you...
- Chronic kidney or liver disease
- Primary hypo- or hyperparathyroidism
- Hypophosphatemic rickets
- Neuromuscular disorders
- Use of corticosteroids or bisphosphonates
- Unclear diagnosis or treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 7 days of trauma
Participants undergo baseline assessments including anthropometric measurements, dietary questionnaires, and blood sample collection to evaluate bone metabolism and vitamin D status within 7 days of trauma.
1 visit (in-person)
Long-term Monitoring
Duration - Up to study completion in 2026
Participants are observed to explore the relationship between vitamin D status, bone metabolic markers, obesity, and fracture risk.
No additional visits; observational follow-up
Trial Site Locations
Total: 2 locations
1
Kaiser Franz Joseph Hospital
Brixen, Bolzano, Italy, 39042
Actively Recruiting
2
Franz Tappeiner Hospital
Meran, Bolzano, Italy, 39012
Actively Recruiting
Loading map...
Research Team
A
Andrea Cosentino, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Comparison of 25-OH vitamin D levels between children with upper and those with lower extremity fractures: A prospective case-control study.
Tuğrul Ergün, Murat Cansever
https://pubmed.ncbi.nlm.nih.gov/35416156Vitamin D levels in Irish children with fractures: A prospective case-control study with 5 year follow-up.
Dave M Moore, Mike O'Sullivan, Pat Kiely...
https://pubmed.ncbi.nlm.nih.gov/33903053Association of serum 25(OH)Vit-D levels with risk of pediatric fractures: a systematic review and meta-analysis.
G Yang, W Y W Lee, A L H Hung...
https://pubmed.ncbi.nlm.nih.gov/33704541Association between bone mass and fractures in children: a prospective cohort study.
Emma M Clark, Andy R Ness, Nicholas J Bishop...
https://pubmed.ncbi.nlm.nih.gov/16939408Global Consensus Recommendations on Prevention and Management of Nutritional Rickets.
Craig F Munns, Nick Shaw, Mairead Kiely...
https://pubmed.ncbi.nlm.nih.gov/26745253