NCT04783428Active, not recruiting
Tumor-induced Osteomalacia Disease Monitoring Program
Tumor-induced Osteomalacia Disease Monitoring Program (TIO DMP)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The objectives of this observational study are to assess the long-term safety and long-term effectiveness of burosumab in patients with TIO who are being treated with burosumab as prescribed by their physician and to monitor the course of the underlying phosphaturic mesenchymal tumor (PMT) overtime in patients with TIO irrespective of their treatment status.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 23 (actual)
- First submitted
- 18 Feb 2021
- Start date
- 31 Jan 2022
- Primary completion date
- 28 Feb 2032
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Diseases
- Childhood cancers
- NCT number
- NCT04783428
What you commit to
- Study type: Observational
- Participants enrolled: 23
- From 31 Jan 2022 to the primary completion date, 28 Feb 2032
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent enrollment in a clinical trial without prior approval from the TIO DMP Sponsor
- Undergoing treatment with burosumab for an unapproved indication
Other illness
- Serious medical or psychiatric comorbidity that, in the opinion of the Investigator, would present a concern for patient safety or compromise the ability to provide consent or comply with the study visit schedule and study procedures
Other
- Have a clinical diagnosis of TIO deemed to be caused by a tumor other than a PMT
- Less than 1 year of life expectancy (for any cause) in the opinion of the Investigator
Who the study is looking for
- Have a clinical diagnosis of TIO based on the presence of an underlying PMT (confirmed by imaging) AND/OR historical documentation. Note: For adult patients with TIO in whom the causative PMT has never been located, and all pediatric patients, documented evidence of negative genetic testing for other hereditary hypophosphatemic disorders is necessary
- For patient safety, all participating female patients of child-bearing potential must be willing to have pregnancy tests prior to certain assessments performed as part of the DMP
- Be willing to provide access to prior medical records including tumor pathology reports and biopsy slides, imaging, biochemical, and diagnostic, medical, and surgical history data, if available
- Be willing and able to provide informed consent after the nature of the study has been explained, and prior to any research-related procedures
- Be willing and able to comply with the study visit schedule and study procedures
Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Bloomington | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.