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NCT Number: NCT07143552

Bone Outcomes, Obesity, Sunlight, and Trauma in Children

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.

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Key information

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Franz Joseph Hospital, Brixen, Bolzano, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Serum 25-hydroxyvitamin D (nmol/L)

    Time frame: within 7 days

    Blood level of vit D

  2. BMI

    Time frame: at baseline

    Relation between BMI and Fracture

Secondary outcomes

  1. Calcium, Phosphate, alkaline phosphatase

    Time frame: within 7 days from trauma

    Serum level of bone metabolism markers

  2. bone risk score

    Time frame: at baseline

    proportion with score ≥3

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Cosentino, MD

CONTACT

[email protected]

+393334503625

Sponsors and collaborators

Lead sponsor

Paracelsus Medical University

Other

Registry information

Official study title

A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures

Acronym: BOOST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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