Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-29 @ 2:20 AM
Study NCT ID:
NCT00453492
Status:
COMPLETED
Last Update Posted:
2008-03-11
First Post:
2007-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risedronate Sodium in Post Menopausal Osteoporosis
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily
Status:
COMPLETED
Status Verified Date:
2008-03
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:
The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.
The secondary objectives are to measure compliance (50 % drug taken), and persistence, \[and urinary NTx (N-telopeptides) (optional)\].
The secondary objectives are to measure compliance (50 % drug taken), and persistence, \[and urinary NTx (N-telopeptides) (optional)\].
Detailed Description:
None
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?: