Hydrocortisone and Placebo in Patients With Partial Adrenal Insufficiency After Cessation of Glucocorticoid Treatment

Overview

Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival.Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population(≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 patients annually discontinue GC treatment. Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency (GIA). The risk of GIA as determined by the adrenal corticotrophic hormone (ACTH) stimulation test is ≈ 25 %,but testing after GC treatment is not routinely performed. In addition, the ACTH stimulation testwas developed for the diagnosis of complete primary adrenal insufficiency, wherefore the clinical value of the ACTH stimulation test in the context of GIA is unknown. When diagnosed, GIA is treated with hydrocortisone (equivalent to cortisol). Excess GC exposure is associated with very serious adverse effects which may also apply to hydrocortisone treatment in patients with GIA. Moreover, hydrocortisone treatment may postpone normalization of adrenal function. On the other hand, GIA patients may develop symptomatic adrenal insufficiency that justifies hydrocortisone treatment. Despite these dilemmas, no evidence-based data exist regarding the proper management of GIA patients. The study is a multi-centre, randomised, double-blinded, placebo controlled 1-year study to compare the effect of hydrocortisone and placebo in patients with Giant Cell Arterititis or Polymyalgia Rheumatica (PMR) with partial adrenal insufficiency after cessation of glucocorticoid treatment.

Full Title of Study: “A Randomised, Placebo Controlled to Compare the Effect of Hydrocortisone and Placebo in Patients With Partial Adrenal Insufficiency After Cessation of Glucocorticoid Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2024

Interventions

  • Drug: Hydrocortisone
    • hydrocortisone
  • Drug: Placebo
    • placebo tablets

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo tablets
  • Active Comparator: Hydrocortisone
    • hydrocortisone tablets

Clinical Trial Outcome Measures

Primary Measures

  • Adrenal insufficiency symptoms
    • Time Frame: 6 months
    • measured by questionaire: AddiQoL-30

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Marianne Andersen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Marianne Andersen, professor – Odense University Hospital
  • Overall Official(s)
    • Marianne S Andersen, Principal Investigator, Odense University Hospital
  • Overall Contact(s)
    • Marianne S Andersen, +4565411807, marianne.andersen1@rsyd.dk

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