Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03162172
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2017-05-16
Brief Title:
Growth Hormone GH in Congenital Adrenal Hyperplasia
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of the Adult Height Gain With Growth Hormone Treatment in Children With Congenital Adrenal Hyperplasia CDAH Using the OPALE Prediction Model
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPALE GH
Brief Summary:
Congenital adrenal hyperplasia CAH is a genetic rare disease which alters the adrenal production of gluco and mineralo corticoids The treatment consists in supplementing children using hydrocortisone Despite care for these children has improve substantially across decades short adult height still remains an important consequence of the disease About 20 of patients have an AH below 2 standard deviations compared to their expected height
In the OPALE model study the investigators have collected data from a cohort of 496 French patients born between 1970 and 1991 and with a known genotype Using their age sex growth disease bone maturation and pubertal data they have built a model which allows to predict their AH using data available at 8 years of age This model has shown that the currently used formula to calculate the predicted AH Bayley Pineaus method is not applicable to children with CAH
In this project the investigators plan to use the prediction model to compare the AH in patients who have received GH treatment to their predicted AH using the model
The hypothesis is that GH improves the AH in such patients Existing cohorts have shown improved growth celerity and growth expectation using the Bayley-Pineau formula but this has not been shown on the actual AH
This study will allow to reinforce the investigators hypothesis
In the OPALE model study the investigators have collected data from a cohort of 496 French patients born between 1970 and 1991 and with a known genotype Using their age sex growth disease bone maturation and pubertal data they have built a model which allows to predict their AH using data available at 8 years of age This model has shown that the currently used formula to calculate the predicted AH Bayley Pineaus method is not applicable to children with CAH
In this project the investigators plan to use the prediction model to compare the AH in patients who have received GH treatment to their predicted AH using the model
The hypothesis is that GH improves the AH in such patients Existing cohorts have shown improved growth celerity and growth expectation using the Bayley-Pineau formula but this has not been shown on the actual AH
This study will allow to reinforce the investigators hypothesis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None