[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549170":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":56,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":10,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Michigan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational cohort",null,"Participants with Cushing syndrome consented to participate in block-and-replace osilodrostat therapy.",[13],"Drug: Osilodrostat",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Osilodrostat","Add methylprednisolone to osilodrostat therapy after first dose and continue during osilodrostat titration.",[9],[21],"Isturisa",[23],{"name":24,"affiliation":5,"role":25},"Richard Auchus, MD, PhD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Richard Auchus","CONTACT","734-764-7764","rauchus@med.umich.edu",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Thaira Blanco Varela","734-647-5661","tbv@med.umich.edu",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-83.74088,42.27756,{"lat":48,"lon":47},[51,54,55],{"name":52,"role":29,"phone":34,"phoneExt":10,"email":53},"Eyad Alsafadi","alsafade@med.umich.edu",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},{"name":24,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":25,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Richard J. Auchus, MD PhD","Professor of Translational Medicine, Professor of Internal Medicine and Professor of Pharmacology",[60],{"name":61,"class":62},"RECORDATI GROUP","INDUSTRY","100549170","a-block-and-replace-therapy-with-osilodrostat-and-concomitant-glucocorticoid-replacement-100549170",false,"NCT06430528","A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement","Inclusion Criteria:\n\n* Endogenous Cushing syndrome, either following surgery or not candidates for surgery\n* Under consideration to receive osilodrostat as part of their clinical care\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).\n* A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.","ALL","18 Years","75 Years",{"count":73,"type":74},12,"ESTIMATED","OBSERVATIONAL","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).\n\nThe investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.",[78,79,80],"Endogenous Cushing Syndrome","Adrenal Insufficiency","Hypercortisolism",[17,82,83,84],"Glucocorticoid","Methylprednisolone","Medrol","2025-08-14",{"date":87,"type":88},"2025-08-20","ACTUAL",{"date":90,"type":88},"2024-07-19",{"date":92,"type":74},"2027-08",{"name":5,"class":6},1]