Status:
RECRUITING
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Lead Sponsor:
Ulla Feldt-Rasmussen
Collaborating Sponsors:
Aarhus University Hospital
Odense University Hospital
Conditions:
Adrenal Insufficiency
Polymyalgia Rheumatica
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental ...
Detailed Description
The study will include patients with PMR/GCA on ongoing prednisolone treatment in a low dose of \> 0 mg/day and ≤5mg/day. Eligible patients will undergo a Synacthen® test and 250 patients with a stimu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05435781
Start Date
June 7 2022
End Date
March 1 2028
Last Update
May 2 2025
Active Locations (3)
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1
Department of Endocrinology, Aarhus University Hospital
Aarhus, Denmark
2
Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
3
Department of Endocrinology, Odense University Hospital
Odense, Denmark