A Phase 4 interventional study of Plenadren and Conventional glucocorticoid therapy in Primary Adrenal Insufficiency and Secondary Adrenal Insufficiency, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-25.
Sponsored by University of Roma La Sapienza · Phase 4, Interventional, and Treatment
This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.
Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving conventional glucocorticoids therapy have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease, infectious, tumors and premature mortality that is more than twice the mortality rate in the background population. Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur.
In this trial a dual-release hydrocortisone preparations that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary and secondary adrenal insufficiency.
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This study's enrollment of 89 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
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Plenadren (modified release hydrocortison) 20-25 or 30 mg oral tablets will be administered once-daily at 8.00 AM in the fasting state The dose is kept the same as patients had before entering the trial.
Drug: Plenadren
Hydrocortisone (dose range 10 to 30) mg will be continued as before entering the study. Cortisone Acetate (dose 25 to 37.5 mg) will be continued as before entering the study. The morning dose will be administered in the fasting state. The total daily dose and timing is not changed during the study period.
Drug: Conventional glucocorticoid therapy
Healthy volunteers will be enrolled as control group
Oral Tablets: 20-25-30 mg
Also known as: Dual-release Hydrocortisone
Oral Tablets: 20-25-30- 37.5 mg
Also known as: Hydrocortisone / Cortisone Acetate
Change from baseline in measurement of weight at 3 and 6 months
Single outcome measurement of body weight (kg).
Time frame: 0, + 3 months, + 6 months
Change from baseline in metabolic status at 3 and 6 months
Composite outcome measure consisting of simultaneous measurment of: Glycaemia, Insulinemia, Homa index, Glycated Haemoglobin, Total Cholesterol, LDL cholesterol, HDL cholesterol, Triglyceredes; the composite outcome measured at 3 and 6 months.
Time frame: 0, + 3 months, + 6 months
Evaluation of immunological profile at baseline 3 and 6 months.
Composite outcome measure consisting of simultaneous measurment of: Full Count Blood Cell, ESR, Fibrinogen, Immunoglobulin, PCR; measured at baseline, 3 and 6 months.
Time frame: 0, + 3 months, + 6 months
Evaluation of bone deposition and resorption markers from baseline at 6 months
Composite outcome measure consisting of simultaneous measurment of: serum calcium, phosphate, parathyroid hormone (PTH), 25OH-vitamin D, phosphate, osteocalcin, bone phosphate alkaline (sBALP), serum-cross-linked N and C-telopeptide of bone type I collagen (NTx- CTx); measure at baseline and 6 months.
Time frame: 0, + 6 months
Evaluation of epicardial fat thickness from baseline at 6 months
Measurement of epicardial fat thickness (EFT) by hihg-resolution M-B-mode transthoracic echocardiography from baseline at 6 months.
Time frame: 0, + 6 months
Evaluation of hepatic steatosis from baseline at 6 months
Evaluation of hepatic steatosis by conventional ultrasound of the liver and with ASQ software with dedicated equipment and 7-5 Mhz convex probe frome baseline at 6 months.
Time frame: 0, + 6 months
Changes in quality of life from baseline at 2, 3 and 6 months
Quality of life will be measured by questionnaires: AddiQol, Middle Sex Hospital Questionnaire (MHQ), International Index of Erectile Function (IIEF), Female Sexual Function Index (FSFI), Beck Depression Inventory Test (BDI-II).
Time frame: 0, + 2 months, +3 months, + 6 months
Bone mineral density
Bone mineral density quantified by Dual X-Ray Absorptiometry (DEXA)
Time frame: 0, + 6 months
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza