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Burosumab in Children and Adolescents With X-linked Hypophosphatemia

B

Bicetre Hospital

Status and phase

Unknown
Phase 4

Conditions

X-linked Hypophosphatemia
Rare Diseases

Treatments

Drug: Burosumab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04419363
20200528104746

Details and patient eligibility

About

In this prospective longitudinal cohort study we studied the efficacy and safety of burosumab in real-clinical practice for <13- and >13-years old children affected with X-linked hypophosphatemia.

57 children with XLH were switched from conventional treatment to burosumab. After 12 months we assessed the efficacy and safety of treatment with burosumab on the whole cohort and separately on the cohort of >13-years old adolescents.

Enrollment

57 estimated patients

Sex

All

Ages

1 to 20 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • insufficient response or refractory to conventional therapy;
  • complications of conventional therapy: hypercalciuria and/or nephrocalcinosis, and/or persistent secondary hyperparathyroidism;
  • need for rapid restoration of phosphate metabolism, e.g., late diagnosis (aged >8 years) and/or preparation for planned orthopaedic surgery.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

The whole cohort
Experimental group
Description:
Children affected with X-linked hypophosphatemia of average age of 9.8 years were switch from conventional therapy to burosumab
Treatment:
Drug: Burosumab Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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