Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004488
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gauchers Disease
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-03
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:
OBJECTIVES
I Determine the efficacy of alendronate sodium in treating osteopenia generalized bone density and focal bone lesions in patients with Gauchers disease
I Determine the efficacy of alendronate sodium in treating osteopenia generalized bone density and focal bone lesions in patients with Gauchers disease
Detailed Description:
PROTOCOL OUTLINE
This is a randomized double blind placebo controlled study
All patients receive oral calcium carbonate and cholecalciferol daily Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months
Patients are followed every 6 months for 2 years
Completion date provided represents the completion date of the grant per OOPD records
This is a randomized double blind placebo controlled study
All patients receive oral calcium carbonate and cholecalciferol daily Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months
Patients are followed every 6 months for 2 years
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHMC-C-498 | None | None | None |
| CHMC-C-FDR001537 | None | None | None |