Tumor-induced Osteomalacia Disease Monitoring Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-31

Study Completion Date

2032-02-28

Brief Summary

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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.

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Detailed Description

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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

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Tumor-induced Osteomalacia (TIO)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prior TIO Burosumab Clinical Trial Participants

No intervention

Intervention Type OTHER

Access to any treatment is through authorized commercial use and not as part of this DMP

Adults Who Have Not Participated In Prior Burosumab Clinical Trials

No intervention

Intervention Type OTHER

Access to any treatment is through authorized commercial use and not as part of this DMP

Pediatrics Who Have Not Participated In Prior Burosumab Clinical Trials

No intervention

Intervention Type OTHER

Access to any treatment is through authorized commercial use and not as part of this DMP

Interventions

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No intervention

Access to any treatment is through authorized commercial use and not as part of this DMP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No