Tumor-induced Osteomalacia Disease Monitoring Program
← catalyst calendarNCT04783428 · readout in 2,019 d
Sponsored by Ultragenyx Pharmaceutical Inc (industry) · RARE — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
23actual
Sites
6
Countries
Argentina, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-31 | actual | When the study began enrolling |
| Primary completion | 2032-02-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-02-28 | estimated | The whole study's end, after follow-up |
| First posted | 2021-03-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Tumor-induced Osteomalacia (TIO)
Intervention
- Other: No intervention
Primary outcomes
what the primary-completion date above is the date OFLong-Term Effectiveness of Burosumab: Change From Baseline in Serum Phosporus Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in Serum 1,25(OH)2D Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in Serum Alkaline Phosphatase (ALP) Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in Serum FGF23 Over Time in Participants Not Undergoing Treatment With Burosumab
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline in Phosphaturic Mesenchymal Tumor (PMT) Size Over Time as Assessed by Tumor Imaging
measured 10 years
Long-Term Safety of Burosumab: Number of Participants With New PMT Development as Assessed by Tumor Imaging
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline in Serum iPTH Over Time
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline in Serum Calcium Over Time
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline in Urine Calcium Over Time
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline Urinary Calcium/Creatinine Ratio
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline in Serum Creatinine Over Time
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline in Urine Creatinine Over Time
measured 10 years
Long-Term Safety of Burosumab: Change From Baseline in Urine Protein/Creatinine Ratio Over Time
measured 10 years
Long-Term Safety of Burosumab: Number of Participants With Nephrocalcinosis Over Time
measured 10 years
Long-Term Safety of Burosumab: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) and Related AEs
measured 10 years
Long-Term Safety of Burosumab: Number of Participants With Incidence and/or Progression of Spinal Stenosis Over Time
measured 10 years
Long-Term Safety of Burosumab: Number of Participants With Normal and/or Potentially Clinically Significant Pregnancy Outcomes
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in Brief Fatigue Inventory (BFI) Scores in Adult Participants Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scores in Pediatric Participants Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in Brief Pain Inventory (BPI) Scores in Adult Participants Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in PROMIS Pain Scores in Pediatric Participants Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in PROMIS Physical Function Scores Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change From Baseline in Short Form-36 version 2 (SF-36v2) in Adult Participants Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Change in Short Form-10 (SF-10) for Pediatric Participants Over Time
measured 10 years
Long-Term Effectiveness of Burosumab: Number of Participants With Changes From Baseline in Clinical Findings
measured 10 years
Long-Term Effectiveness of Burosumab: Number of Participants With Changes From Baseline in Resource/Health Utilization
measured 10 years
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