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A Retrospective Observational Study Of The Effect Of Dosing Regimen Of Burosumab On Biochemical Control Of Serum Phosphate Levels In Patients With X-Linked Hypophosphataemia XLH

Nottingham

Posted about 1 month ago

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Actively Recruiting

Age: 2Years - 18Years

All Genders

ID07183579

A Retrospective Observational Study of the Effect of Dosing Regimen of Burosumab on Biochemical Control of Serum Phosphate Levels in Patients With X-linked Hypophosphataemia XLH

Led by: University of Nottingham

Updated on: 2026-05-11

120 Participants Needed

1 Research Sites

Total Duration

AI-Summary

What This Trial Is About

X-linked hypophosphataemia XLH is a rare genetic disorder caused by mutations in the PHEX gene, leading to low blood phosphate levels and reduced vitamin D. This causes soft bones, rickets, skeletal deformities, growth failure, and bone and dental pain. Conventional treatment with oral phosphate and vitamin D supplements can be burdensome and leave symptoms. Burosumab Crysvita, a monoclonal antibody targeting FGF23, is now the standard treatment for children with XLH, but optimal dosing is still being studied. This retrospective observational study collects data from multiple pediatric metabolic bone centers in England to assess the effectiveness of starting Burosumab at less than 0.8 mg/kg every two weeks compared to the standard 0.8 mg/kg dose. It reviews data from children and young people with XLH who have received at least 12 months of continuous Burosumab treatment under pediatric guidelines. Data include blood markers, growth measurements, treatment timing, imaging results, and adverse effects, all collected from routine health records and anonymized for analysis. Participants will not have direct contact with researchers. Their existing medical records are reviewed to analyze biochemical control of serum phosphate levels, growth changes, dosing variations, and safety over one year of treatment. The study aims to improve understanding of real-world Burosumab dosing to support better, safer, and cost-conscious care for children with XLH.

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Brief Title

Effective Dosing of Burosumab in XLH

Who Can Participate

Age: 2Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of X-linked hypophosphataemia (XLH), including genetic confirmation of a PHEX mutation
Received at least 12 months of continuous Burosumab treatment under pediatric criteria
Treatment started before the 18th birthday
Age between 2 and 18 years at enrollment

You will not qualify if you...

Received Burosumab under adult dosing criteria (data from adult treatment excluded, but pediatric treatment data included if available)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - At least 12 months

Participants who have received at least 12 months of continuous Burosumab treatment are observed through review of existing clinical records as part of routine care, including biochemical, auxological, imaging, and adverse event data collection.

Data extracted from routine clinical visits over 12 months

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Trial Site Locations

Total: 1 location

Nottingham University Hospitals NHS Trust
- Nottingham, United Kingdom, NG7 2UH

Actively Recruiting

Research Team

James M Law, BMBS, PhD, MRCPCH

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

Frequently Asked Questions

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Research Publications

New Developments in the Treatment of X-Linked Hypophosphataemia: Implications for Clinical Management.
- Vrinda Saraff, Ruchi Nadar, Wolfgang Högler
- https://pubmed.ncbi.nlm.nih.gov/31965544
Clinical guidelines for burosumab in the treatment of XLH in children and adolescents: British paediatric and adolescent bone group recommendations.
- Raja Padidela, Moira S Cheung, Vrinda Saraff...
- https://pubmed.ncbi.nlm.nih.gov/33112809
Burosumab versus conventional therapy in children with X-linked hypophosphataemia: a randomised, active-controlled, open-label, phase 3 trial.
- Erik A Imel, Francis H Glorieux, Michael P Whyte...
- https://pubmed.ncbi.nlm.nih.gov/31104833
Burosumab Therapy in Children with X-Linked Hypophosphatemia.
- Thomas O Carpenter, Michael P Whyte, Erik A Imel...
- https://pubmed.ncbi.nlm.nih.gov/29791829

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