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This study will compare the efficacy and safety of the two 11β-hydroxylase inhibitors-metyrapone and osilodrostat-in patients with MACS.
Primary outcome To compare the efficacy (biochemical and clinical) of the two 11β-hydroxylase inhibitors (CYP11B1), metyrapone and osilodrostat, in patients with MACS not treated surgically (mainly bilateral adenomas or adrenal hyperplasias), as well as their side effects at time 0-, 3- and 6-months post-treatment.
Secondary outcome To evaluate alterations in clinical parameters (Blood Pressure, Body Mass Index-BMI), metabolic parameters (fasting blood glucose, insulin, Hb1Ac, HOMA, OGTT and lipids levels) at time 0-, 3- and 6-month after the initiation of the treatment and their effect on Bone Mineral Density (BMD) 1 year post-diagnosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MACS | Other | Patients with MACS (Adults > 18 years old with 1mg ODST F levels >1.8μg/dl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metyrapone 250 mg Oral Tablets | Drug | metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the efficacy of metyrapone and osilodrostat | Blood tests measuring baseline moring cortisol (μg/dl) levels pre and post-treatment | Baseline ( at t=0), at t=3 months and at =6 months |
| Comparison of the efficacy of metyrapone and osilodristat | Measurement of the baseline morning ACTH (pg/ml) pre and post-treatment | Baseline (at t= 0), at t= 3 months and t= 6 months |
| Comparison of the efficacy of metyrapone and osilodristat | Measurement of the baseline morning DHEAS levels (μg/dl) pre and post-treatment | Baseline ( at t=0), at t=3 months and at t=6 months |
| Comparison of the efficacy of metyrapone and osilodristat | Measurement of urinary free cortisol (μg/24h) pre and post-treatment | Baseline ( at t=0), at t=3 months and at =6 months |
| Comparison of metyrapone and osilodrostat efficacy | Measurement of salivary midnight cortisol (μg/dl) pre and post-treatment | Baseline (at t=0), at t=3 months , at t =6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alteartions of LDL levels (mg/dl) pre and post-treatment | Baseline (t=0), at t= 3months, at t=6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alterations of fasting blood glucose levels (mg/dl) pre and post-treatment | Baseline at t=0 , at 3 months and at 6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of metyrapone and osilodrostat in terms of other parameters | Alterations of systolic and diastolic blood pressure (mmHg) at morning pre and post-treatment | Baseline (t=0), at t=3 months and t=6 months |
| Comparison of metyrapone and osilodrostat in terms of other parameters |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Angelousi, MD, PhD, Msc | Contact | 00306978167876 | 0030 | a.angelousi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laikon General Hospital | Recruiting | Athens | Greece |
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| ID | Term |
|---|---|
| D008797 | Metyrapone |
| C553306 | Osilodrostat |
| D013514 | Surgical Procedures, Operative |
| D000315 | Adrenalectomy |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013507 | Endocrine Surgical Procedures |
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|
| Osilodrostat 1 MG | Drug | administration of 1-3 mg of osilodrostat at 19.00 |
|
| adrenalectomy | Procedure | Surgery performed in patients with MACS |
|
| Watch and wait | Other | Follow-up |
|
Alteration of insuline levels (μU/ml) pre and post-treatment |
| Baseline (t=0), at t=3 months and at t=6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alterations of Hb1Ac levels (%) pre and post-treatment | Baseline (t=0), at t=3 months and at t=6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alterations of HOMA-IR (glucose levels mmol/l x insuline levels mIU/L/22.5) pre and post -treatment | Baseline (t=0) at t=3 months and t=6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alterations of cholesterol levels (mg/dl) pre and post-treatment | Baseline (t=0), at t=3 months and at t=6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alterations of triglycerides levels (mg/dl) pre and post-treatment | Baseline (t=0), at t=3 months and at t=6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alterations of HDL levels (mg/dl) pre and post-treatment | Baseline (t=0), at t=3 months and at t=6 months |
| Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters | Alterations of glucose levels post-OGTT pre and post-treatment | Baseline at t=0, at t=3 months , at t=6 months |
Alterations of BMI (weight (kg) / height(cm2)) levels pre and post-treatment |
| Baseline (t=0), t=3 months , t=6 months |
| Comparison of metyrapone and osilodrostat in terms of other parameters | Alterations of bone mineral density (BMD) in gr /cm3 pre and post-treatment | Baseline at t=0 and at t= 1 year |