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Not yet recruiting NCT07607600

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

— Observational X-linked Hypophosphatemia (XLH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No treatment given.
Who it may be relevant to
Registry conditions: X-linked Hypophosphatemia (XLH). Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, France, Germany +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other No treatment given
    No treatment given

Primary outcome measures

  • Average Trough Serum Phosphate Concentration [Time frame: From baseline to last assessment (Up to 3 years)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 5 centers
  • Fukuoka University - Fukuoka University Hospital — Fukuoka
  • Okayama Saiseikai Outpatient Center Hospital — Okayama
  • The University of Tokyo Hospital — Bunkyo-ku
  • Iseikai International General Hospital — Osaka
  • Japan Community Healthcare Organization Osaka Hospital — Osaka
United States · 4 centers
  • Yale University School of Medicine — New Haven
  • Indiana University Hospital — Indianapolis
  • The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East — Columbus
  • Vanderbilt University Medical Center — Nashville
Italy · 4 centers
  • Office of Francesco Di Costanzo, MD — Sesto Fiorentino
  • Istituto Auxologico Italiano — Milan
  • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia — Padova
  • Fondazione Policlinico Universitario Campus Bio-Medico — Rome
Australia · 3 centers
  • Northern Sydney Cancer Centre-Royal North Shore Hospital (RNSH) — St Leonards
  • Westmead Hospital — Westmead
  • Monash University - Monash Medical Centre (MMC) — Clayton
Germany · 3 centers
  • Charite Campus Virchow — Berlin
  • Endokrinologikum Goettingen — Göttingen
  • Universitat Wurzburg Koenig-Ludwig-Haus — Wuezburg
France · 2 centers
  • CHU de Bicetre — Le Kremlin
  • Hopital Cochin - APHP — Paris
Canada · 1 center
  • Bone Research and Education Centre — Oakville
Netherlands · 1 center
  • Leiden University Medical Center (Leids Universitair Medisch Centrum (LUMC)) — Leiden

Identifiers

NCT: NCT07607600 · NN8661-8325

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗