Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398931
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2006-11-10
Brief Title:
FLEX - Long-term Extension of FIT Fracture Intervention Trial0217-051
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A 5-year Double-blind Randomized Placebo-controlled Extension Study to Examine the Long-term Safety and Efficacy of Oral Alendronate in Postmenopausal Women Who Previously Received Alendronate in Conjunction With the Fracture Intervention Trial
Status:
COMPLETED
Status Verified Date:
2022-02
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:
This study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial FIT Participants in the FLEX study were randomly assigned to receive alendronate either 5 or 10 mgday or matching placebo during the next 5 years in order to evaluate the effects of continuing or discontinuing alendronate treatment on bone mineral density and biochemical markers of bone turnover
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 |
|---|---|---|---|
| 2006_558 | None | None | None |