Bone Outcomes, Obesity, Sunlight, and Trauma in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pediatric Fractures, Hypovitaminosis D, Obesity and Overweight. Basic parameters: 3 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
Overview
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.
Detailed description
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.
Primary outcome measures
- Serum 25-hydroxyvitamin D (nmol/L) [Time frame: within 7 days]
- BMI [Time frame: at baseline]
Secondary outcome measures (2)
- Calcium, Phosphate, alkaline phosphatase [Time frame: within 7 days from trauma]
- bone risk score [Time frame: at baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 2 centers
- Kaiser Franz Joseph Hospital — Brixen
- Franz Tappeiner Hospital — Meran
Publications
- Gonzalez N, Nahmias J, Schubl S, Swentek L, Smith BR, Nguyen NT, Grigorian A. Obese adolescents have higher risk for severe lower extremity fractures after falling. Pediatr Surg Int. 2023 Jul 19;39(1):235. doi: 10.1007/s00383-023-05524-9. PMID 37466766
- Ergun T, Cansever M. Comparison of 25-OH vitamin D levels between children with upper and those with lower extremity fractures: A prospective case-control study. Acta Orthop Traumatol Turc. 2022 Mar;56(2):76-80. doi: 10.5152/j.aott.2022.21018. PMID 35416156
- Moore DM, O'Sullivan M, Kiely P, Noel J, O'Toole P, Kennedy J, Moore DP, Kelly P. Vitamin D levels in Irish children with fractures: A prospective case-control study with 5 year follow-up. Surgeon. 2022 Apr;20(2):71-77. doi: 10.1016/j.surge.2021.02.015. Epub 2021 Apr 24. PMID 33903053
- Yang G, Lee WYW, Hung ALH, Tang MF, Li X, Kong APS, Leung TF, Yung PSH, To KKW, Cheng JCY, Lam TP. Association of serum 25(OH)Vit-D levels with risk of pediatric fractures: a systematic review and meta-analysis. Osteoporos Int. 2021 Jul;32(7):1287-1300. doi: 10.1007/s00198-020-05814-1. Epub 2021 Mar 11. PMID 33704541
- Clark EM, Ness AR, Bishop NJ, Tobias JH. Association between bone mass and fractures in children: a prospective cohort study. J Bone Miner Res. 2006 Sep;21(9):1489-95. doi: 10.1359/jbmr.060601. PMID 16939408
- Munns CF, Shaw N, Kiely M, Specker BL, Thacher TD, Ozono K, Michigami T, Tiosano D, Mughal MZ, Makitie O, Ramos-Abad L, Ward L, DiMeglio LA, Atapattu N, Cassinelli H, Braegger C, Pettifor JM, Seth A, Idris HW, Bhatia V, Fu J, Goldberg G, Savendahl L, Khadgawat R, Pludowski P, Maddock J, Hypponen E, Oduwole A, Frew E, Aguiar M, Tulchinsky T, Butler G, Hogler W. Global Consensus Recommendations on P PMID 26745253
Identifiers
NCT: NCT07143552 · prot. N. 0098306-BZ REG01