This study aims to compare the use of methylprednisolone and hydrocortisone as replacement therapies in patients with glucocorticoid-induced adrenal insufficiency.
The primary goal is to evaluate and compare the recovery of the hypothalamic-pituitary-adrenal (HPA) axis.
Age over 18 years.
Suspected adrenal insufficiency due to receiving supraphysiological doses of methylprednisolone for more than 4 weeks.
Receiving methylprednisolone 4 mg for at least the last 4 weeks.
Morning cortisol lower than 300 nmol/L.
Known organic disease of the pituitary-adrenal axis.
Body mass over 130 kg.
Advanced comorbidities.
Advanced heart failure (NYHA IV).
Parallel
Patients will receive 3 mg of methylprednisolone once daily. The dose is administered in the morning (1 ½ tablets of 2 mg Medrol after breakfast).
DrugPatients will receive 3 mg of methylprednisolone once daily. The dose is administered in the morning (1 ½ tablets of 2 mg methylprednisolone after breakfast).
Patients will receive 15 mg of hydrocortisone daily. The dose is split into 10 mg in the morning after breakfast and 5 mg after 6-7 hours.
DrugPatients will receive 15 mg of hydrocortisone daily. The dose is split into 10 mg in the morning after breakfast and 5 mg after 6-7 hours.
Proportion of patients with recovery of the HPA axis.
Replacement therapy for glucocorticoid-induced adrenal insufficiency with methylprednisolone in a physiologically equivalent morning dose is being evaluated for non-inferiority compared to hydrocortisone. Methylprednisolone is considered not inferior regarding the proportion of patients with HPA axis recovery after 12 months, provided the difference between the groups does not exceed the pre-specified non-inferiority margin of 10%. Recovery of the HPA axis is assessed via a short ACTH test, defined as a cortisol rise to at least 470 nmol/L after 30 minutes or at least 500 nmol/L after 60 minutes.
Secondary Analysis: Superiority of Methylprednisolone
If the non-inferiority of methylprednisolone is confirmed, we will also evaluate the superiority of methylprednisolone as part of the secondary analyses: The proportion of patients with recovery of the HPA axis will be higher after 12 months in the group receiving methylprednisolone.
Non-inferiority of Methylprednisolone at 24 Months
Methylprednisolone is not inferior to hydrocortisone in the treatment of glucocorticoid-induced adrenal insufficiency after 24 months. The difference in the proportion of patients with HPA axis recovery between the groups does not exceed the pre-specified non-inferiority margin (15%).
Number of adrenal crises.
Time required for HPA axis recovery based on the duration of previous glucocorticoid treatment.
Click on the lead sponsor to view all of their trials.
University Medical Centre Ljubljana
Lead sponsor
University of Ljubljana
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
