ECE2023 Eposter Presentations Adrenal and Cardiovascular Endocrinology (124 abstracts)
REPLACE: Effect of hydrocortisone and placebo in patients with partial adrenal insufficiency after cessation of glucocorticoid treatment; A study protocol for a multi-centre, randomised, double-blinded, placebo-controlled clinical trial
Anja Fenger Dreyer 1,2 , Stina Willemoes Borresen 3 , Simon Bøggild Hansen 4,5 , Hajir Al-Jorani 1,2 , Lise Sofie Bislev 4 , Victor Brun Boesen 3 , Louise Lehmann Christensen 1,2 , Dorte Glintborg 1,2 , Richard Christian Jensen 1 , Nanna Thurmann Jørgensen 3,6 , Marianne Klose 3 , Marie Louise Lund 3,6 , Jelena Stankovic 4,5 , Randi Tei 4 , Torquil Watt 3,6 , Ulla Feldt-Rasmussen 3,6 , Jens Otto Jørgensen 4,5 & Marianne Andersen 1,2
1Odense University Hospital, Department of Endocrinology, Odense, Denmark; 2University of Southern Denmark, Department of Clinical Research, Faculty of Health Sciences, Odense, Denmark; 3Copenhagen University Hospital, Department of Endocrinology and Metabolism, Rigshospitalet, Copenhagen, Denmark; 4Aarhus University Hospital, Department of Endocrinology and Internal Medicine, Aarhus, Denmark; 5Aarhus University, Department of Clinical Medicine, Aarhus, Denmark; 6Copenhagen University, Department of Clinical Medicine, Faculty of Health and Clinical Sciences, Copenhagen, Denmark
Background: Glucocorticoid (GC) formulations are widely used as anti-inflammatory treatment, and synthetic GC, e.g. prednisolone, is the cornerstone treatment of polymyalgia rheumatic (PMR) and giant cell arteritis (GCA). Long-term pharmacological GC treatment may induce adrenal insufficiency (GIA). Adrenal function is, however, not routinely assessed after discontinuation of long-term GC treatment, and it is unknown, if hydrocortisone replacement is beneficial. This study aims to generate evidence-based guidance for the management of GIA due to long-term GC treatment.
Methods: The REPLACE study is a multi-centre, randomised, double-blinded, placebo controlled 1-year study. Participants are patients diagnosed with PMR and/or GCA, who have been in GC free remission for 2-12 weeks after long-term prednisolone treatment. Eligible patients undergo an ACTH test, and group assignment depends on the cortisol response: In both RCT and control groups a fasting, standardized baseline visit includes patient reported outcome (PRO), physical and psychological health. Patients in the RCT are randomized to either hydrocortisone or placebo for 1 year with repetition of baseline investigations at 6 and 12 months.
Outcomes: Primary outcome: Health related quality of life associated with adrenal insufficiency assessed by the Addison’s disease-specific quality-of-life questionnaire (AddiQol-30).
Secondary outcomes: Using a study smartphone application (app), participant-reported information about intercurrent illness or stress, and symptoms attributable to adrenal insufficiency, are reported daily. Furthermore, ecological momentary assessments of the Multidimensional Fatigue Inventory, General Fatigue scale, are reported in the app in both stressed and unstressed conditions.
Exploratory outcomes: Additional questionnaire-based HRQoL (CushingQoL, SF-36v2, Single item Sleep Quality Scale and the International Physical Activity Questionnaire-S7S); incidence of adrenal crisis; cardiovascular health (blood pressure, arterial stiffness and coagulation markers); body composition and muscle function (DXA scan and physical tests); bone and calcium metabolism; glucose homeostasis; possibly normalization of adrenal function; and biomarkers of GC sensitivity and action.
Ethics and dissemination: The REPLACE study is in accordance with the Declaration of Helsinki; registered at EudraCT (2020-006121-65) and publications will be according to the International Committee of Medical Journal Editors recommendations.
| RCT-group | Cortisol level >100 nmol/l and <420 nmol/l | n=150 |
| Partial adrenal insufficiency | ||
| Control group 1 | Cortisol level <100 nmol/l | n=20 |
| Adrenal insufficiency | ||
| Control group 2 | Cortisol level >420 nmol/l | n=60 |
| Normal adrenal function | ||
Funding: The REPLACE study is funded by the Novo Nordisk Foundation as part of a collaborative grant entitled "DOUBLE EDGE–Characterization and mitigation of adverse effects of glucocorticoid treatment" (NNF20OC0063280).
Status: Recruiting.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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