RECRUITINGOBSERVATIONAL
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Treatments Being Tested
DRUG
Osilodrostat
Add methylprednisolone to osilodrostat therapy after first dose and continue during osilodrostat titration.
Locations (1)
University of Michigan
Ann Arbor, Michigan, United States