Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
782 participants
OBSERVATIONAL
2018-07-16
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prior Burosumab Clinical Trial Participants
Patients who participated in burosumab clinical trials and continue to receive burosumab via prescription from their physician.
No intervention
Access to any treatment is through authorized commercial use and not as a part of this DMP
Not from Prior Burosumab Clinical Trial
Patients may take other treatments for XLH and may start burosumab treatment at any time as prescribed by a physician.
No intervention
Access to any treatment is through authorized commercial use and not as a part of this DMP
Interventions
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No intervention
Access to any treatment is through authorized commercial use and not as a part of this DMP
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of XLH based on family history, OR confirmed PHEX mutation, OR biochemical profile consistent with XLH.
* Willing and able to comply with the study visit schedule and study procedures.
Exclusion Criteria
* Serious medical or psychiatric comorbidity.
* Less than one year of life expectancy.
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Ultragenyx Pharmaceutical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Ultragenyx Medical Director
Role: STUDY_DIRECTOR
Ultragenyx Pharmaceuticals Inc.
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University - Department of Medicine
Nashville, Tennessee, United States
Vanderbilt University - Department of Pediatrics
Nashville, Tennessee, United States
Houston Methodist Research Institute
Houston, Texas, United States
University of Texas, Health Science Center
Houston, Texas, United States
University of Virgina School of Medicine
Charlottesville, Virginia, United States
Children's Hospital of The King's Daughter
Norfolk, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
American Family Children's Hospital
Madison, Wisconsin, United States
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina
Hospital de Niños Dr. Ricardo Gutierrez
Buenos Aires, , Argentina
Hospital Privado Universitario de Córdoba
Córdoba, , Argentina
Hospital Universitário Alcides Carneiro (HUAC)
São José, Campina Grande - PB, Brazil
Instituto de Medicina Avancada (IMA Brasil)
São Paulo, São Paulo, Brazil
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Bone Research and Education Centre
Oakville, Ontario, Canada
Shiner's Hospital for Children - Canada
Montreal, Quebec, Canada
Children's Hospital Eastern Ontario Research Institute
Ottawa, , Canada
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, Chile
Hospital Universitario de San Vicente Fundación
Medellín, Antioquia, Colombia
Hospital Infantil Universitario de San José
Bogotá, Cundinamarca, Colombia
Countries
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References
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Carpenter TO, Fukumoto S, Haffner D, Imel EA, Ozono K, Ishii H, Li Z, Sandilands K, Joos-Vandewalle P, Lee C, Kanematsu M, McCullough KP, Brandi ML. Advancing Patient Evidence in XLH (APEX): Baseline analysis of a global data unification program. Bone. 2025 Dec;201:117649. doi: 10.1016/j.bone.2025.117649. Epub 2025 Sep 15.
Related Links
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Ultragenyx Transparency Commitment
Other Identifiers
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UX023-CL401
Identifier Type: -
Identifier Source: org_study_id
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