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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.
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.
The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.
Age
50 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Research Site
Birmingham, Alabama, United States
Research Site
Oakland, California, United States
Research Site
San Diego, California, United States
Research Facility
Walnut Creek, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Lakewood, Colorado, United States
Research Site
Leesburg, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Gainesville, Georgia, United States
Start Date
October 1, 2007
Primary Completion Date
April 1, 2010
Completion Date
April 1, 2010
Last Updated
April 22, 2013
923
ACTUAL participants
risedronate
DRUG
risedronate
DRUG
risedronate
DRUG
Lead Sponsor
Warner Chilcott
NCT05010590
NCT07329543
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05060380