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Study identifier: NCT04159675 Synced from ClinicalTrials.gov · July 28, 2026
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Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts

Condition: Craniosynostoses  ·  Sponsor: Hospices Civils de Lyon

PhaseN/A
Planned participants20
Who can joinAll sexes, 4 Months to 18 Years
Healthy volunteersNo

About this study

FGF23 is the cornerstone of phosphate / calcium / vitamin D metabolism: it is synthesized mainly by osteocytes and acts as a phosphaturizing agent, inhibitor of dihydroxyvitamin D, and inhibitor of synthesis and secretion of PTH in most tissues. The specific role of FGF23 on bone has yet to be demonstrated. In osteoblasts, overexpression of FGF23 in vitro suppresses not only osteoblastic differentiation but also the synthesis of the mineralized matrix independently of its systemic action on phosphate metabolism. In osteoblasts, FGF23 also regulates the secretion of osteopontin by directly suppressing transcription of alkaline phosphatase. In some diseases such as hypophosphatemic rickets (HR), the direct role of FGF23 on bone has not yet been studied to our knowledge, whereas these genetic hypophosphatemias are secondary to overexpression of FGF23, whether an activating mutation of FGF23 or inhibitory mutations of its inhibitors (DMP1 and PHEX). However, patients with X-linked hypophosphatemic rickets (XLH) have higher circulating FGF23 levels than healthy controls and these levels are higher in treated patients. Management of XLH consists primarily of correcting the native vitamin D defect by prescribing active vitamin D analogs as well as phosphate supplementation to improve bone mineralization and decrease dental complications, growth, and bone deformities. Recently, a new therapeutic option has been developed for XLH, burosumab, a human monoclonal antibody that binds a…

This description comes directly from the study's public registry record.

Talk to the study team

Federico DI ROCCO, MD  ·  04 72 35 75 72  ·  federico.dirocco@chu-lyon.fr

Justine BACCHETTA, MD  ·  0427856178  ·  justine.bacchetta@chu-lyon.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Centre de référence des craniosténoses et malformations cranio-faciales Service de neurochirurgie PédiatriqueBron, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04159675