A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Michigan
About this trial
The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach).
The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.
Eligibility criteria
Qualifiers
Endogenous Cushing syndrome, either following surgery or not candidates for surgery
Under consideration to receive osilodrostat as part of their clinical care
Able to provide informed consent.
Disqualifiers
Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).
A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.
Trial design
Treatments tested in this trial
- Osilodrostat
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Michigan
Lead sponsor
RECORDATI GROUP
Collaborator
Source ClinicalTrials.gov