Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorNovo Nordisk A/S

About this trial

The purpose of this study is to better understand how X-linked hypophosphatemia (XLH) affects the body and daily life. Phosphate levels are critical in managing XLH, we aim to study how these levels change in patients taking burosumab and how they relate to bone health, overall disease burden and XLH-related conditions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent obtained before any trial-related activities, i.e., any procedure related to recording of data according to the protocol.

Male or female and aged 18-64 years (both inclusive) at the time of signing informed consent.

Diagnosis of congenital XLH, confirmed genetically or clinically as determined by the investigator, supported by documentation.

Participants have been treated with burosumab for at least 90 days prior to the screening/baseline visit and treatment is still ongoing.

Disqualifiers

Previous rescreening for this trial.

Current participation in any interventional clinical trial. Participation in another non-interventional trial, such as a patient registry trial, is permitted.

Any condition not associated with XLH, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Trial population

Adults with XLH, confirmed genetically or clinically as determined by the investigator, who have been treated with burosumab for at least 90 days prior to the screening/baseline visit and whose treatment is still ongoing. Participants will be followed for a maximum of three years, continuing until end of trial visit, withdrawal of consent or loss to follow-up, whichever occurs first.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No treatment given

    Other intervention

    No treatment given

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Adults with XLH1 intervention

Trial outcomes

Primary outcomes

1

Average Trough Serum Phosphate Concentration

Average trough serum phosphate concentration, defined as the area under the concentration-time curve (AUC) divided by the total duration of the assessment period (AUC divided by time). Measured in milligrams per deciliter (mg/dL).

Time frame
From baseline to last assessment (Up to 3 years)

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: