Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106028
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2005-03-18
Brief Title:
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Sponsor:
Warner Chilcott
Organization:
Warner Chilcott
Study Overview
Official Title:
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Children with Osteogenesis Imperfecta OI have bone pain low bone mass and fractures There are no approved drugs for the treatment of OI in children even though some intravenous IV bisphosphonates are used off-label in some countries In a single dose pharmacokinetic study data showed that risedronate was well tolerated in 28 children with OI This three year study will test the safety and efficacy of risedronate in the treatment of children with OI For the first year patients will be randomized to the risedronate and placebo groups in a 21 ratio For the second and third years of the study all patients will receive risedronate
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 |
|---|---|---|---|
| HMR4003I3001 | None | None | None |