A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Richard Auchus
rauchus@med.umich.edu
734-764-7764
Backup
Thaira Blanco Varela
tbv@med.umich.edu
734-647-5661
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2027-08
Participants
Target number of participants: 12
Treatments
Observational cohort
Participants with Cushing syndrome consented to participate in block-and-replace osilodrostat therapy.
Related Therapeutic Areas
Sponsors
Collaborators: Recordati Rare Diseases
Leads: University of Michigan