Bone Outcomes, Obesity, Sunlight, and Trauma in Children

NCT07143552 | Recruiting

• 1 other identifier: prot. N. 0098306-BZ REG01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pediatric Fractures; Hypovitaminosis D; Obesity and Overweight

Keywords

Vitamin D; Alkaline phosphatase; Calcium; Case-control; bmi; phosphate; Low-energy trauma

Outcome Measures

Primary Outcomes (2)

• Serum 25-hydroxyvitamin D (nmol/L)

  Blood level of vit D

  within 7 days

• BMI

  Relation between BMI and Fracture

  at baseline

Secondary Outcomes (2)

• Calcium, Phosphate, alkaline phosphatase

  within 7 days from trauma

• bone risk score

  at baseline

Study Arms (2)

Fracture group

Children aged 3-15 years with radiologically confirmed low-energy fractures.

Control group

Children aged 3-15 years with low-energy trauma but no radiological evidence of fracture.

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents aged 3 to 15 years presenting to emergency services after low-energy trauma. Eligible participants include those with radiologically confirmed fractures (case group) and those with comparable trauma without fractures (control group). All participants are otherwise healthy and free from chronic conditions or treatments that may influence bone metabolism.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (2)

Kaiser Franz Joseph Hospital

Brixen, Bolzano, 39042, Italy

RECRUITING

Franz Tappeiner Hospital

Meran, Bolzano, 39012, Italy

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Prevention and Management of Nutritional Rickets. J Clin Endocrinol Metab. 2016 Feb;101(2):394-415. doi: 10.1210/jc.2015-2175. Epub 2016 Jan 8.

  PMID: 26745253 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Obesity; Overweight

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Cosentino, MD

  Franz Tappeiner Hospital; Paracelsus Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Cosentino, MD

CONTACT

+393334503625; andrea.cosentino@stud.pmu.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator, Department of Orthopedics, Attending PhD

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: July 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

IT (2)