Tumor-induced Osteomalacia Disease Monitoring Program (TIO DMP)

Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale University
New Haven
Indiana
Indiana University
Bloomington
Maryland
Johns Hopkins University
Baltimore
Tennessee
Vanderbilt University Medical Center
Nashville
Virginia
University of Virginia
Charlottesville
Other Locations
Argentina
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas
Buenos Aires
Time Frame
Start Date: 2022-01-31
Completion Date: 2032-02-28
Participants
Target number of participants: 22
Treatments
Prior TIO Burosumab Clinical Trial Participants
Adults Who Have Not Participated In Prior Burosumab Clinical Trials
Pediatrics Who Have Not Participated In Prior Burosumab Clinical Trials
Related Therapeutic Areas
Sponsors
Leads: Ultragenyx Pharmaceutical Inc

This content was sourced from clinicaltrials.gov