CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 205 enrolled
Drug / intervention
150 mg +2 moredrug
Likely dose
150 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00918749
NCT00918749Phase 2Completed
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Study Assessing the Efficacy, Safety, and Pharmacokinetics of 75 and 100 mg Once-a-month Delayed-release Risedronate Formulations Compared to 150 mg Once-a-month Immediate-release Risedronate for 3 Months in Postmenopausal Women Age 45-80

Warner Chilcott·interventional·Posted Jun 11, 2009·Updated Jun 29, 2015

In Brief

A Phase 2 clinical trial evaluating 150 mg, 75 mg, and 1 other intervention for Postmenopausal Osteoporosis. Completed, enrolled 205 participants across 6 sites.

Detailed Summary

Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2009
Enrollment StartMay 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.1 years ago

Interventions

150 mgdrug

150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.

75 mgdrug

75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

100 mgdrug

100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast