Effectiveness and safety of burosumab in an Early Access Program: a study of UK adults with X-linked hypophosphataemia

Early Access experience with burosumab in adults with X-linked hypophosphataemia in the UK: real-world clinical and patient-reported outcomes

Registry ID
ISRCTN13102817
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
Kyowa Kirin International (United Kingdom)
Enrollment
144
Start date
2023-07-18
Completion date
2023-10-31
Last update
2026-08-17

Conditions

Summary

X-linked hypophosphataemia (XLH)

Detailed description

UK centres with patients enrolled in the burosumab Early Access Program are sites in this observational study. Investigators collect data from patients' medical records, including patient-reported outcomes, that were recorded during participants' normal clinical care. No additional tests or instruments were used for the purposes of this study. Key parameters that will be abstracted, if available, from medical records include: 1. Patient characteristics, demographics and relevant medical history 2. Medications, including analgesics, and treatment history 3. Serum phosphate, alkaline phosphatase, parathyroid hormone, calcium and vitamin D 4. Patient-reported outcomes including Brief Pain Inventory Short Form (BPI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and EQ-5D-5L 5. Burosumab exposure and adverse events

Interventions

Inclusion criteria

All participants enrolled in the burosumab early access programme (EAP) will be considered for inclusion

Exclusion criteria

Participants opting out will not have their clinical data collected

Locations

Related clinical trials

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