Effects of Burosumab and Vitamin D on Bone Cells in Children with Craniosynostosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ASO Therapy for Syndromic Craniosynostosis

  This project tests patient-specific antisense oligonucleotides to see if they can address the molecular drivers of syndromic craniosynostosis in young children who are undergoing surgical skull remodelling.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome · NCT07535372

• Finding the right burosumab dose for children with XLH

  This project tests whether children with X-linked hypophosphataemia can achieve good phosphate control on starting burosumab doses below 0.8 mg/kg.

  Recruiting University of Nottingham · Nottingham · NCT07183579

• Monitoring blood flow during surgery for craniosynostosis

  This study is testing new ways to monitor blood flow during surgery for craniosynostosis in infants to see if they can make the procedure safer and more effective.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, BO · NCT06263075

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.