Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2012-08-31
Brief Summary
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Randomization will be stratified based on previous DMARDs in the investigation that may be different for different patients, knowing that France hydrocortisone and dexamethasone are used mainly for the treatment of congenital adrenal hyperplasia. The judging criteria will be: i) the criteria of adrenal hormone suppression: plasma levels of testosterone, androstenedione, 17 OHP, ACTH and diurnal variations of the 17 OH progesterone salivary ii) the criteria of the metabolic impact of glucocorticoids: plasma glucose levels , blood lipids, and insulin sensitivity index HOMA-R calculated from glucose and insulin, iii) the criteria of bone impact of glucocorticoids: plasma for CTX bone resorption and bone alkaline phosphatase P1NP for bone formation iv) the living quality criteria evaluated by the PGWB Questionnaire (Psychological General Well-Being). The duration of the study period will be 24 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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A: hydrocortisone
hydrocortisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Hormonal balance measurements
metabolic balance measurements
bone balance measurements
quality of life assessment
B :dexamethasone (DECTANCYL)
dexamethasone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Hormonal balance measurements
metabolic balance measurements
bone balance measurements
quality of life assessment
C : prednisone (CORTANCYL)
prednisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Hormonal balance measurements
metabolic balance measurements
bone balance measurements
quality of life assessment
Interventions
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Hormonal balance measurements
metabolic balance measurements
bone balance measurements
quality of life assessment
Eligibility Criteria
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Inclusion Criteria
* Suffering from congenital adrenal hyperplasia in its classical form with salt loss or pure virilizing
* Patients who have presented signs of congenital adrenal hyperplasia in its classical form (salt wasting syndrome and / or neonatal masculinization) with elevation of 17 OH progesterone with diagnosis of enzyme block 21 hydroxylase.
* Patients currently treated by: 1 or 2 Oral compound glucocorticoid as replacement and suppressive therapy + 1 mineralocorticoid if necessary with effective control of substitution + possibly by estrogen-progestin pill.
Exclusion Criteria
* Postmenopausal women, age over 55 years
* Concomitant therapy: glucocorticoids supra-physiological doses for other indications, bisphosphonates, vitamin D, oral antidiabetic agents or insulin, lipid lowering agents (eg inflammatory disease, asthma, systemic disease ... ..).
* participation of the subject to another biomedical research protocol for this study
* Inability to submit to medical monitoring study for geographical, social or psychological.
* Severe calorie diet planned or carried out during the study.
18 Years
55 Years
FEMALE
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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Service Endocrinologie et Maladies Métaboliques
Caen, , France
Countries
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Facility Contacts
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Other Identifiers
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11-059
Identifier Type: -
Identifier Source: org_study_id
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