Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001221
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effect of Biosynthetic Growth Hormone andor Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Trial of the Effect of Biosynthetic Growth Hormone andor Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome
Status:
COMPLETED
Status Verified Date:
2003-09
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:
None
Brief Summary:
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes Girls with Turner syndrome are very short as children and as adults Although their growth hormone secretion is almost always normal giving injections of growth hormone to Turner syndrome girls may increase their rate of growth In addition most girls with Turner syndrome do not have normal ovaries
In normal girls the ovaries begin producing small amounts of the female sex hormone estrogen at about 11 - 12 years of age As girls grow older the level of estrogen increases Estrogen is responsible for the changes in girls known as feminization During feminization the hips grow wider the breasts develop there is an increase in the rate of growth and eventually girls experience their first menstrual period
This study was designed to evaluate the effect of low dose estrogen growth hormone and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups
1 Group one will receive low dose estrogen
2 Group two will receive growth hormone
3 Group three will receive both low dose estrogen and growth hormone
4 Group four will receive a placebo sugar pill
Once started the treatment will continue until the patients approach their adult height and growth slows to less than 12 inch over the preceding year This usually occurs by the age of 15 or 16
Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests and handwrist X-rays to determine bone age On patients yearly visits they will have the density of bone measured in their spine and forearm
In normal girls the ovaries begin producing small amounts of the female sex hormone estrogen at about 11 - 12 years of age As girls grow older the level of estrogen increases Estrogen is responsible for the changes in girls known as feminization During feminization the hips grow wider the breasts develop there is an increase in the rate of growth and eventually girls experience their first menstrual period
This study was designed to evaluate the effect of low dose estrogen growth hormone and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups
1 Group one will receive low dose estrogen
2 Group two will receive growth hormone
3 Group three will receive both low dose estrogen and growth hormone
4 Group four will receive a placebo sugar pill
Once started the treatment will continue until the patients approach their adult height and growth slows to less than 12 inch over the preceding year This usually occurs by the age of 15 or 16
Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests and handwrist X-rays to determine bone age On patients yearly visits they will have the density of bone measured in their spine and forearm
Detailed Description:
Adult women with Turners syndrome are quite short Several treatments have been used to increase growth rate in these patients They include oxandrolone 1 growth hormone 2 3 and low dose estrogen 4 However the ability of these hormone treatments to increase adult height has never been evaluated in controlled clinical trials
We propose to evaluate the effect on adult height of low dose estrogen growth hormone and the combination of low dose estrogen and growth hormone Patients will be entered into the study from ages 5 to 12 and will be assigned randomly to one of the four groups the 3 above treatment groups or placebo The randomized assignment will be double-blind throughout the study Treatment will be maintained to adult height the first height measurement at which the preceding annual growth rate was 15 cm Beginning at age 12 the estrogen treatment in all 4 groups will be changed to a standardized regimen of increasing estrogen dose so that all children in the study will undergo secondary sexual changes at an appropriate age
In addition the study will assess the effect of growth hormone and estrogen treatment on bone density and in a parallel separate study the effect of treatment on cognition and learning ability
We propose to evaluate the effect on adult height of low dose estrogen growth hormone and the combination of low dose estrogen and growth hormone Patients will be entered into the study from ages 5 to 12 and will be assigned randomly to one of the four groups the 3 above treatment groups or placebo The randomized assignment will be double-blind throughout the study Treatment will be maintained to adult height the first height measurement at which the preceding annual growth rate was 15 cm Beginning at age 12 the estrogen treatment in all 4 groups will be changed to a standardized regimen of increasing estrogen dose so that all children in the study will undergo secondary sexual changes at an appropriate age
In addition the study will assess the effect of growth hormone and estrogen treatment on bone density and in a parallel separate study the effect of treatment on cognition and learning ability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 87-CH-0152 | None | None | None |