Tumor-induced Osteomalacia Disease Monitoring Program

Korábbi kezelés

• Concurrent enrollment in a clinical trial without prior approval from the TIO DMP Sponsor
• Undergoing treatment with burosumab for an unapproved indication

Más betegség

• 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

Egyéb

• Have a clinical diagnosis of TIO deemed to be caused by a tumor other than a PMT
• Less than 1 year of life expectancy (for any cause) in the opinion of the Investigator

• 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