NCT04783428

Tumor-induced Osteomalacia Disease Monitoring Program

Tumor-induced Osteomalacia Disease Monitoring Program (TIO DMP)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Ultragenyx Pharmaceutical Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Enrolled patients may or may not be treated with commercially available burosumab during the TIO DMP at the discretion of their treating physician. Given the observational nature of the TIO DMP, specific treatments or supportive management will not be provided as part of the study.

Conditions

• Tumor-induced Osteomalacia (TIO)

Interventions

Type	Name	Description
OTHER	No intervention	Access to any treatment is through authorized commercial use and not as part of this DMP

Timeline

• Start date: 2022-01-31
• Primary completion: 2032-02-28
• Completion: 2032-02-28
• First posted: 2021-03-05
• Last updated: 2026-01-21

Locations

6 sites across 2 countries: United States, Argentina

Regulatory

• FDA-regulated drug study