Hydrocortisone vs. placebo for adrenal insufficiency symptoms after stopping glucocorticoids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of hydrocortisone compared to a placebo in patients experiencing symptoms of adrenal insufficiency after discontinuing glucocorticoid treatment. The study focuses on individuals aged 50 and older who have been in remission from polymyalgia rheumatica or giant cell arteritis for a specified period after glucocorticoid therapy. The aim is to assess the incidence of glucocorticoid-induced adrenal insufficiency and determine the efficacy of hydrocortisone in alleviating symptoms. Participants will be monitored for their response to treatment over the course of the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 50 years
* A diagnosis of PMR or GCA in GC free remission for \>2 week and \<12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks

Exclusion Criteria:

* Known primary or secondary adrenal insufficiency
* Known Cushing´s syndrome
* Heart failure (New York Heart Association class IV)
* Kidney failure with an estimated glomerular filtration rate \<30 mL/min
* Liver cirrhosis
* Active cancer
* Known severe immune deficiency
* A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)
* Alcohol consumption \>21 units per week
* Planned major surgery during the study period at study entry
* Use of drugs that interfere with cortisol metabolism/measurements:
* Systemic oestrogen treatment within 1 month before study inclusion
* Strong CYP3A4 inhibitors or inducers
* Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area
* Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area
* Inability to provide written informed consent

Where it's running

• Department of Endocrinology and Internal Medicine, Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Department of Nephrology and Endocrinology, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Endocrinology, Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Marianne S Andersen — Odense University Hospital
• Study coordinator: Marianne S Andersen
• Email: marianne.andersen1@rsyd.dk
• Phone: +4565411807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.