Идёт набор NCT07268222

Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)

Фаза IV С лечением Mild Autonomous Cortisol Secretion (MACS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Metyrapone 250 mg Oral Tablets, Osilodrostat 1 MG, adrenalectomy, Watch and wait.
Кому может быть актуально: Состояния в реестре: Mild Autonomous Cortisol Secretion (MACS). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Греция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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

Вмешательства

Препарат Metyrapone 250 mg Oral Tablets
metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS
Препарат Osilodrostat 1 MG
administration of 1-3 mg of osilodrostat at 19.00
Процедура adrenalectomy
Surgery performed in patients with MACS
Другое Watch and wait
Follow-up

Первичные конечные точки

Comparison of the efficacy of metyrapone and osilodrostat [Срок оценки: Baseline ( at t=0), at t=3 months and at =6 months]
Comparison of the efficacy of metyrapone and osilodristat [Срок оценки: Baseline (at t= 0), at t= 3 months and t= 6 months]
Comparison of the efficacy of metyrapone and osilodristat [Срок оценки: Baseline ( at t=0), at t=3 months and at t=6 months]
Comparison of the efficacy of metyrapone and osilodristat [Срок оценки: Baseline ( at t=0), at t=3 months and at =6 months]
Comparison of metyrapone and osilodrostat efficacy [Срок оценки: Baseline (at t=0), at t=3 months , at t =6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline (t=0), at t= 3months, at t=6 months]

Вторичные конечные точки (8)

Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline at t=0 , at 3 months and at 6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline (t=0), at t=3 months and at t=6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline (t=0), at t=3 months and at t=6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline (t=0) at t=3 months and t=6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline (t=0), at t=3 months and at t=6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline (t=0), at t=3 months and at t=6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline (t=0), at t=3 months and at t=6 months]
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters [Срок оценки: Baseline at t=0, at t=3 months , at t=6 months]

Критерии участия

Критерии включения

Adults > 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia (based on imaging)
1 mg overnight dexamethasone suppression test (ODST): Cortisol levels at 8.00 am>1.8 μg/dl AND i) ACTH< 15 pg/ml OR ii) abnormal midnight salivary cortisol OR iii) Urinary free cortisol levels (UFC) /24h ≥ of the UNL