Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ultragenyx Pharmaceutical Inc
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Tumor-induced Osteomalacia Disease Monitoring Program
