Pediatric FracturesBOOSTNCT07143552
Bone Outcomes, Obesity, Sunlight, and Trauma in Children
An observational study of Pediatric Fractures and Hypovitaminosis D, run by Paracelsus Medical University at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Fractures, Hypovitaminosis D, Obesity and Overweight
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 3-15 years;
- low-energy trauma;
- cases = radiographic fracture; controls = no fracture.
Who cannot join
- chronic renal/liver disease;
- primary hypo-/hyperparathyroidism;
- hypophosphatemic rickets;
- neuromuscular disorders;
- corticosteroids/bisphosphonates;
- unclear diagnosis/treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Kaiser Franz Joseph Hospital
Brixen, Bolzano, 39042
Andrea Cosentino, MD, +39 3334503625, andreacosentino2@gmail.com
- Recruiting
Franz Tappeiner Hospital
Meran, Bolzano, 39012
Andrea Cosentino, MD, +393334503625, andrea.cosentino@sabes.it
About this study
Official title: A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
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.
Read the 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.
- Keywords
- Vitamin D, Alkaline phosphatase, Calcium, Case-control, bmi, phosphate, Low-energy trauma
- Medical subject headings
- Vitamin D Deficiency, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D (nmol/L)
Blood level of vit D
Measured: within 7 days
BMI
Relation between BMI and Fracture
Measured: at baseline
Secondary outcomes (2)
Calcium, Phosphate, alkaline phosphatase
Serum level of bone metabolism markers
Measured: within 7 days from trauma
bone risk score
proportion with score ≥3
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Jul 2024
- Primary completionJan 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pediatric FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Cosentino, Paracelsus Medical University
- Investigators
- Andrea Cosentino, MD, Principal investigator, Franz Tappeiner Hospital; Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143552
- Sponsor's protocol ID
- prot. N. 0098306-BZ REG01
- Acronym
- BOOST
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37466766Ergun 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.
PubMed 35416156Moore 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.
PubMed 33903053Yang 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.
PubMed 33704541Clark 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.
PubMed 16939408Munns 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.
PubMed 26745253Cosentino A, Weghuber D, Indelli PF, Fantini N, Berger W, Schmidt OS, Hogler W. Vitamin D status and adiposity in children with low-energy fractures: a prospective case-control study. Eur J Pediatr. 2026 Oct 9;185(11):820. doi: 10.1007/s00431-026-07509-x.
PubMed 42850326
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case-Control Study of Vitamin D Status, Bone Metabolic Markers, and Overweight in Pediatric Low-Energy Fractures
- ClinicalTrials.gov ID
- NCT07143552
- Acronym / sponsor ID
- BOOST / prot. N. 0098306-BZ REG01
- Keywords
- Vitamin D, Alkaline phosphatase, Calcium, Case-control, bmi, phosphate, Low-energy trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 3-15 years;
- low-energy trauma;
- cases = radiographic fracture; controls = no fracture.
Key exclusion criteria (6 listed)
- chronic renal/liver disease;
- primary hypo-/hyperparathyroidism;
- hypophosphatemic rickets;
- neuromuscular disorders;
- corticosteroids/bisphosphonates;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum 25-hydroxyvitamin D (nmol/L)
Time frame: within 7 days
Blood level of vit D
BMI
Time frame: at baseline
Relation between BMI and Fracture
2 secondary outcomes
Calcium, Phosphate, alkaline phosphatase
Time frame: within 7 days from trauma
bone risk score
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 37466766Gonzalez 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.
- Background: PubMed 35416156Ergun 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.
- Background: PubMed 33903053Moore 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.
- Background: PubMed 33704541Yang 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.
- Background: PubMed 16939408Clark 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.
- Background: PubMed 26745253Munns 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.
- Derived from this study: PubMed 42850326Cosentino A, Weghuber D, Indelli PF, Fantini N, Berger W, Schmidt OS, Hogler W. Vitamin D status and adiposity in children with low-energy fractures: a prospective case-control study. Eur J Pediatr. 2026 Oct 9;185(11):820. doi: 10.1007/s00431-026-07509-x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Cosentino, MD principal investigator
Franz Tappeiner Hospital; Paracelsus Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Fractures and Hypovitaminosis D, run by Paracelsus Medical University at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Cosentino, MD (+393334503625, andrea.cosentino@stud.pmu.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25-hydroxyvitamin D (nmol/L) (time frame: within 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07143552, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.