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COrticosteroid in Congenital Adrenal Hyperplasia (COCA)

Primary Purpose

Congenital Adrenal Hyperplasia

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Hormonal balance measurements
metabolic balance measurements
bone balance measurements
quality of life assessment
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Congenital Adrenal Hyperplasia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Service Endocrinologie et Maladies MétaboliquesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A: hydrocortisone

B :dexamethasone (DECTANCYL)

C : prednisone (CORTANCYL)

Arm Description

hydrocortisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks

dexamethasone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks

prednisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks

Outcomes

Primary Outcome Measures

hormonal parameters
6 points salivary 17 OHP cycle, and 8 am plasma ACTH,testosterone and androstenedione

Secondary Outcome Measures

parameters of bone turnover:
CTX and bone alkaline phosphatase P1NP
metabolic parameters:
blood glucose and insulin, cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol
Quality of Life
Psychological General Well-Being questionnaire

Full Information

First Posted
July 27, 2015
Last Updated
September 15, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02552251
Brief Title
COrticosteroid in Congenital Adrenal Hyperplasia
Acronym
COCA
Official Title
Comparative Study of the Use of Glucocorticoids in the Treatment of Congenital Adrenal Hyperplasia in Its Classical Form
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Adrenal Hyperplasia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: hydrocortisone
Arm Type
Experimental
Arm Description
hydrocortisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Arm Title
B :dexamethasone (DECTANCYL)
Arm Type
Experimental
Arm Description
dexamethasone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Arm Title
C : prednisone (CORTANCYL)
Arm Type
Experimental
Arm Description
prednisone equivalent to physiological doses for each patient Strategy: administration of glucocorticoids during sequences of eight weeks
Intervention Type
Biological
Intervention Name(s)
Hormonal balance measurements
Intervention Type
Biological
Intervention Name(s)
metabolic balance measurements
Intervention Type
Biological
Intervention Name(s)
bone balance measurements
Intervention Type
Behavioral
Intervention Name(s)
quality of life assessment
Primary Outcome Measure Information:
Title
hormonal parameters
Description
6 points salivary 17 OHP cycle, and 8 am plasma ACTH,testosterone and androstenedione
Time Frame
change over baseline, week 8, week 16, week 24
Secondary Outcome Measure Information:
Title
parameters of bone turnover:
Description
CTX and bone alkaline phosphatase P1NP
Time Frame
change over baseline, week 8, week 16, week 24
Title
metabolic parameters:
Description
blood glucose and insulin, cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol
Time Frame
change over baseline, week 8, week 16, week 24
Title
Quality of Life
Description
Psychological General Well-Being questionnaire
Time Frame
change over baseline, week 8, week 16, week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Service Endocrinologie et Maladies Métaboliques
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves REZNIK, MD, PhD
Phone
02.31.06.45.86
Email
reznik-y@chu-caen.fr

12. IPD Sharing Statement

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COrticosteroid in Congenital Adrenal Hyperplasia

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