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Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)

NCT02304367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-05-06

Study results available
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Summary

The primary objectives of this study are to evaluate the effect of burosumab treatment on:

* Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia
* Improvement in TIO/ENS-associated osteomalacia as determined by osteoid thickness (O.Th), osteoid surface/bone surface (OS/BS), osteoid volume/bone volume (OV/BV) and mineralization lag time (MLt).

Conditions

  • Tumor Induced Osteomalacia (TIO)
  • Epidermal Nevus Syndrome (ENS)

Interventions

BIOLOGICAL

Burosumab

Solution for subcutaneous injection

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Ultragenyx Pharmaceutical Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-24
Primary Completion
2017-07-27
Completion
2021-01-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304367 on ClinicalTrials.gov