Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209469
Status:
UNKNOWN
Last Update Posted:
2005-09-21
First Post:
2005-09-12
Brief Title:
Network Osteoporosis Study
Sponsor:
Glaser Pediatric Research Network
Organization:
Glaser Pediatric Research Network
Study Overview
Official Title:
Double Blind Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid-Associated Osteopenia and Osteoporosis
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications
Detailed Description:
This trial will test the hypothesis that among 90 children and adolescents with Crohns disease ulcerative colitis systemic-onset juvenile rheumatoid arthritis juvenile dermatomyositis systemic lupus erythematosus mixed connective tissue disease and vasculitis treatment of glucocorticoid-associated osteopenia and osteoporosis with 18 months of alendronate FOSAMAX Merck Co Inc will result in greater improvement in the mean change of individual AP spine bone mineral density BMD gmcm2 determined by dual energy X-ray absorptiometry DXA than treatment with 18 months of standard of care therapy
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