Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT00541658
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2007-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Sponsor:
Warner Chilcott
Organization:
Study Overview
Official Title:
A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.
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:
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Detailed Description:
The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.
Study Oversight
Has Oversight DMC:
False
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?: