Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
NCT07120763
Agnosia, Distal Radius Fracture Reduction
Buffalo, New York, United States
View Trial DetailsNCT Number: NCT07143552
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.
Interested in participating?
Request Info3 year–15 year
All sexes
Observational
Kaiser Franz Joseph Hospital, Brixen, Bolzano, Italy
Low-energy fractures in children are a common cause of morbidity and may reflect underlying skeletal fragility. Emerging evidence suggests that hypovitaminosis D, obesity, and abnormal bone metabolism play important roles in fracture risk. However, the combined effect of these factors remains insufficiently studied, particularly in pediatric populations.
This study is designed as a prospective case-control investigation to explore the relationship between vitamin D status, bone metabolic markers, and obesity in children presenting with trauma. Children aged 3-15 years with low-energy trauma will be recruited and divided into two groups: those with radiologically confirmed fractures (cases) and those with similar trauma but without fractures (controls).
Baseline assessments include anthropometric measurements, dietary calcium intake through a food-frequency questionnaire, and laboratory evaluation of bone metabolism. Blood samples will be obtained within 7 days of the trauma and processed under standardized conditions to measure 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), alkaline phosphatase (ALP), calcium, and phosphate. Samples are collected non-fasting and stored on ice to minimize variability in PTH measurement.
The primary outcome is the association of fracture occurrence with serum alkaline phosphatase (ALP) levels. Secondary outcomes include serum calcium, 25OHD concentration, a composite bone risk score, and body mass index (BMI) percentile. Outcomes are analyzed using descriptive statistics, group comparisons, and logistic regression to identify independent predictors of fracture risk.
The study aims to provide novel insights into the multifactorial etiology of pediatric fractures. By integrating metabolic, nutritional, and anthropometric data, the project seeks to establish a more comprehensive risk profile that can guide preventive strategies and inform clinical practice in pediatric bone health.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 7 days
Blood level of vit D
Time frame: at baseline
Relation between BMI and Fracture
Time frame: within 7 days from trauma
Serum level of bone metabolism markers
Time frame: at baseline
proportion with score ≥3
Contact information is provided by the study sponsor or research team.
Paracelsus Medical University
Other
A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
Acronym: BOOST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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