Bone Outcomes, Obesity, Sunlight, and Trauma in Children

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Serum 25-hydroxyvitamin D (nmol/L) [Срок оценки: within 7 days]
• BMI [Срок оценки: at baseline]

Вторичные конечные точки (2)

• Calcium, Phosphate, alkaline phosphatase [Срок оценки: within 7 days from trauma]
• bone risk score [Срок оценки: at baseline]

Критерии участия

Критерии включения

• 3-15 years;
• low-energy trauma;
• cases = radiographic fracture; controls = no fracture.

Критерии исключения

• chronic renal/liver disease;
• primary hypo-/hyperparathyroidism;
• hypophosphatemic rickets;
• neuromuscular disorders;
• corticosteroids/bisphosphonates;
• unclear diagnosis/treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 2 центра

• Kaiser Franz Joseph Hospital — Brixen
• Franz Tappeiner Hospital — Meran

Публикации

• 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

Идентификаторы

NCT: NCT07143552 · prot. N. 0098306-BZ REG01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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