Effects of Burosumab and Vitamin D on Bone Cells in Children with Craniosynostosis
Effect of Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts From Patients Requiring Craniosynostosis Surgery for Idiopathic Reason or Due to Hypophosphatemic Rickets (HR)
This study is testing how the combination of Burosumab and Vitamin D affects bone health in children with craniosynostosis who are preparing for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 4 Months to 18 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | burosumab |
| Locations | 1 site (Bron) |
| Trial ID | NCT04159675 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of FGF23 in bone metabolism, particularly focusing on its effects on osteoblasts in children with craniosynostosis. It aims to understand how FGF23 influences osteoblastic differentiation and mineralized matrix synthesis, which are critical for bone health. The study will include children aged 4 months to 18 years who are scheduled for craniosynostosis surgery and will be monitored for their response to treatments involving Burosumab and Vitamin D. The findings could provide insights into the underlying mechanisms of bone disorders related to phosphate metabolism.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 months to 18 years requiring surgery for craniosynostosis and have not been treated with corticosteroids for more than three months.
Not a fit: Patients currently on oral corticosteroids or those who have received prolonged corticosteroid treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of bone health in children with craniosynostosis and lead to improved treatment strategies.
How similar studies have performed: While the specific role of FGF23 in bone has not been extensively studied, related research on phosphate metabolism and bone health suggests potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children from 4 months-old to 18 years-old * Patients requiring craniosynostosis surgery followed by reference centers for rare diseases of calcium and phosphate metabolism / craniofacial malformations * Patients and parent / holder of parental authority who have been informed of the study and do not object to participate Exclusion Criteria: * Patient being treated with oral corticosteroid or having received more than 3 months of corticosteroid treatment before surgery.
Where this trial is running
Bron
- Centre de référence des craniosténoses et malformations cranio-faciales Service de neurochirurgie Pédiatrique — Bron, France (Recruiting)
Study contacts
- Principal investigator: Federico DI ROCCO, MD — Hospices Civils de Lyon Centre de référence des craniosténoses et malformations cranio-faciales Service de neurochirurgie Pédiatrique
- Study coordinator: Federico DI ROCCO, MD
- Email: federico.dirocco@chu-lyon.fr
- Phone: 04 72 35 75 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.