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COrticosteroid in Congenital Adrenal Hyperplasia (COCA)

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ClinicalTrials.gov Identifier: NCT02552251
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

Congenital adrenal hyperplasia (CAH) results from a deficiency of a key enzyme in the biosynthesis of cortisol, mainly 21-hydroxylase, resulting in its classic form a neonatal salt loss syndrome and / or a virilization syndrome in girls. The treatment of the disorder in adulthood involves administering steroidal compounds with the aim to substitute the gluco- and mineralocorticoid deficit on the one hand, and effectively curb the adrenal hyperplasia and adrenal androgen pathway in girls . The terms of glucocorticoid treatment are not clearly codified and are based on several steroidal compounds and various protocols. The advantages in terms of adrenal suppression and disadvantages - including bone and metabolic - different treatments have not been clearly established in the literature. The main objective of this study is to compare among adults with HCS in its classical form the impact on hormonal parameters adrenal suppression glucocorticoid of 3 types of treatment administered to equivalent dose and according to the usual procedures. The secondary objective is to compare in the same patients the impact of different drugs and treatments on several metabolic bone parameters. The study will include 40 adult patients bearing a HCS in its classical form and will include 3 treatment sequences of eight weeks each, during which they will be administered sequentially in random order at random and according to the known equivalences hydrocortisone, prednisone (CORTANCYL) and dexamethasone (DECTANCYL).

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.


Condition or disease Intervention/treatment Phase
Congenital Adrenal Hyperplasia Biological: Hormonal balance measurements Biological: metabolic balance measurements Biological: bone balance measurements Behavioral: quality of life assessment Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparative Study of the Use of Glucocorticoids in the Treatment of Congenital Adrenal Hyperplasia in Its Classical Form
Study Start Date : August 2012
Estimated Primary Completion Date : December 2015


Arm Intervention/treatment
Experimental: A: hydrocortisone
hydrocortisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Biological: Hormonal balance measurements
Biological: metabolic balance measurements
Biological: bone balance measurements
Behavioral: quality of life assessment
Experimental: B :dexamethasone (DECTANCYL)
dexamethasone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Biological: Hormonal balance measurements
Biological: metabolic balance measurements
Biological: bone balance measurements
Behavioral: quality of life assessment
Experimental: C : prednisone (CORTANCYL)
prednisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Biological: Hormonal balance measurements
Biological: metabolic balance measurements
Biological: bone balance measurements
Behavioral: quality of life assessment



Primary Outcome Measures :
  1. hormonal parameters [ Time Frame: change over baseline, week 8, week 16, week 24 ]
    6 points salivary 17 OHP cycle, and 8 am plasma ACTH,testosterone and androstenedione


Secondary Outcome Measures :
  1. parameters of bone turnover: [ Time Frame: change over baseline, week 8, week 16, week 24 ]
    CTX and bone alkaline phosphatase P1NP

  2. metabolic parameters: [ Time Frame: change over baseline, week 8, week 16, week 24 ]
    blood glucose and insulin, cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol

  3. Quality of Life [ Time Frame: change over baseline, week 8, week 16, week 24 ]
    Psychological General Well-Being questionnaire



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pubescent women over 18 in genital activity (premenopausal)
  • 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:

  • Liver disease, kidney, bone, diabetes, severe dyslipidemia, pregnancy
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552251


Locations
France
Service Endocrinologie et Maladies Métaboliques Recruiting
Caen, France, 14000
Contact: Yves REZNIK, MD, PhD    02.31.06.45.86    reznik-y@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02552251     History of Changes
Other Study ID Numbers: 11-059
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hyperplasia
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Hydrocortisone
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs