Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005112
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-04-15
Brief Title:
Growth Hormone Use in Cystic Fibrosis - a Multicenter Study
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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:
Cystic Fibrosis CF is the most common lethal genetic disorder in America Previous studies by our group and others have shown that human recombinant growth hormone GH improves height velocity weight velocity lean body mass LBM and pulmonary function These positive results have prompted us to ask further questions regarding GH use in CF including a Do patients with better baseline body weight and pulmonary function derive more benefit from treatment than those with worse weight and pulmonary function b Does GH use improve the patients quality of life c Once GH is discontinued are the positive effects sustained We hypothesize that GH treatment in CF patients will improve their clinical status and their quality of life We further hypothesize that these effects will be present regardless of baseline body weight or pulmonary function and that positive outcome will be sustained for at least one year after GH treatment is discontinued To test our hypothesis we will recruit 40 prepubertal children from five CF centers across the United States 8 per center Patients will be randomly assigned to receive treatment with GH 03mgkgwk during either the first or the second year All subjects will be seen every three months We will evaluate the following parameters every three months 1 height height velocity and Z-score 2 body weight and weight velocity Every six months we will measure 1 lean body mass utilizing DEXA 2 pulmonary function including measurement of respiratory muscle strength peak inspiratory and peak expiratory pressure 3 quality of life QOL quantitated from QOL forms specific for CF The Cystic Fibrosis Questionnaire After one year of study subjects will cross-over to the other treatment arm This 24 month study will allow us to statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple centers and will allow us to assess sustained effect in the 20 subjects who receive GH during the first year by comparing their results to results obtained during the year post treatment
Detailed Description:
None
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 |
|---|---|---|---|
| M01RR002558 | NIH | None | httpsreporternihgovquickSearchM01RR002558 |