Supplemental hydrocortisone for adrenal insufficiency during stress

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 supplemental hydrocortisone compared to a placebo in patients with polymyalgia rheumatica (PMR) or giant cell arteritis (GCA) who are experiencing glucocorticoid-induced adrenal insufficiency while on low-dose prednisolone. The study is double-blinded and randomized, focusing on health-related quality of life, particularly fatigue, during periods of mild to moderate stress. Participants will be monitored for their cortisol levels and will receive either hydrocortisone or placebo during stressful situations over a duration of six months. The trial also includes a reference group of patients with normal adrenal function for comparison.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 50 years
* Women must be postmenopausal (FSH is measured at the screening visit)
* A diagnosis of PMR/GCA, or both conditions combined.
* Treatment with prednisolone ≥12 weeks
* Ongoing prednisolone treatment, with current daily prednisolone dose \> 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.

Exclusion Criteria:

* Known primary or secondary adrenal insufficiency
* Known Cushing's Syndrome
* Known allergy towards study medication ingredients
* Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate \<30 mL/min (Chronic kidney disease stage 4-5); Liver disease in the form of 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 (discontinued \< 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. Note: Permitted glucocorticoid formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only.)
* Inability to provide written informed consent.

Where it's running

• Department of Endocrinology, Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Endocrinology, Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Ulla Feldt-Rasmussen, Professor — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Marianne Klose, MD, PhD
• Email: marianne.christina.klose.01@regionh.dk
• Phone: +4530237532

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Understanding genetic factors in Giant Cell Arteritis and Polymyalgia Rheumatica

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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.