Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353080
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2006-07-13
Brief Title:
Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Two-year Multicenter Double-blind Randomized Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women More Than 5 Years Postmenopausal
Status:
COMPLETED
Status Verified Date:
2009-12
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:
To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women
To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption
To confirm general safety of 5 mg daily risedronate as compared to placebo
To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption
To confirm general safety of 5 mg daily risedronate as compared to placebo
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 |
|---|---|---|---|
| HMR4003B3001 | None | None | None |