Clinical trial · Observational
Tumor-induced Osteomalacia Disease Monitoring Program
Tumor-induced Osteomalacia Disease Monitoring Program (TIO DMP)
NCT04783428CI-TRIAL-00113440active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor-induced Osteomalacia (TIO) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Prior TIO Burosumab Clinical Trial Participants
- interventionNames
- Other: No intervention
- label
- Adults Who Have Not Participated In Prior Burosumab Clinical Trials
- interventionNames
- Other: No intervention
- label
- Pediatrics Who Have Not Participated In Prior Burosumab Clinical Trials
- interventionNames
- Other: No intervention
Primary outcomes (26)
- measure
- Long-Term Effectiveness of Burosumab: Change From Baseline in Serum Phosporus Over Time
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Have a clinical diagnosis of TIO deemed to be caused by a tumor other than a PMT * 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 * Less than 1 year of life expectancy (for any cause) in the opinion of the Investigator * Concurrent enrollment in a clinical trial without prior approval from the TIO DMP Sponsor * Undergoing treatment with burosumab for an unapproved indication
References
Publications (0)
Data not yet available
No reference posted for this study.