To investigate the effects of hydrocortisone replacement in participants with previous PMR and GCA, who are in GC-free remission and exhibit biochemical evidence of mild to moderate adrenal insufficiency. MedDRA version: 20.0 Level: LLT Classification code 10001369 Term: Adrenal insufficiency NOS System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Hydrocortison orion
Product Name: Hydrocortison
Product Code: H02AB09
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrokortison
CAS Number: C21H30O5
Current Sponsor code: 000
Other de
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Age = 50 years A diagnosis of PMR or GCA in GC free remission for >2 week and =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: Exclusion criteria Known primary or secondary adrenal insufficiency Known Cushing´s syndrome Severe comorbidity: Heart failure (New York Heart Association class IV) Kidney failure with an estimated glomerular filtration rate 21 units per week Planned major surgery during the study period at study entry. Use of drugs that interfere with cortisol metabolism/measurements: Estrogen treatment (discontinued < 1 month before inclusion) Strong CYP3A4 inhibitors or inducers Use of other GC formulations: Inhaled corticosteroids, intra-articular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area Permitted GC formulations: Eye-drops, nasal spray, GC 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of hydrocortisone replacement in participants with previous PMR and GCA, who are in GC-free remission and exhibit biochemical evidence of mild to moderate adrenal insufficiency.;Secondary Objective: NA;Primary end point(s): Primary outcome •Adrenal insufficiency symptoms (AddiQoL-30) ;Timepoint(s) of evaluation of this end point: 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary outcomes • Participant-reported symptoms of fatigue assessed with EMA-MFI and PRO-CTCAE • Questionnaire-based HRQoL (other than AddiQoL-30) • Incidence of adrenal crises, hospitalizations, sick days, diagnoses and therapy • Cardiovascular health (blood pressure, arterial stiffness, and coagulation markers) • Body composition and muscle function • Normalization of adrenal function evaluated by ACTH test Other secondary endpoints • Glucose homeostasis • Bone and calcium metabolism • Circulating and tissue biomarkers of GC sensitivity and action ;Timepoint(s) of evaluation of this end point: 6 an 12 months | — |
Countries
Denmark
Contacts
Public ContactDept Endocrinology
Odense University Hospital
Outcome results
None listed