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

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.

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Key information

Conditions

X-linked Hypophosphatemia (XLH) Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Familial Hypophosphatemic Rickets Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hypophosphatemia Hypophosphatemia, Familial Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders Renal Tubular Transport, Inborn Errors Rickets Rickets, Hypophosphatemic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Sydney Cancer Centre-Royal North Shore Hospital (RNSH), St Leonards, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Participant confirms ability and willingness to attend visits according to routine clinical care and mandatory assessments at the site.

Exclusion criteria

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.

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

Average Trough Serum Phosphate Concentration

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

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Treatment Patterns, Biochemical Profiles and Clinical Outcomes in Adults With X-Linked Hypophosphatemia - A Prospective Observational Cohort Study - IBIS XLH

Acronym: IBIS XLH

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: May 26, 2026
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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