CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Risedronate +1 moredrug
Likely dose
Risedronate 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01249261
NCT01249261Phase 3Completed

A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numbers)

Warner Chilcott·interventional·Posted Nov 29, 2010·Updated Nov 2, 2011

In Brief

A Phase 3 clinical trial evaluating Risedronate and Placebo/Risedronate for Postmenopausal Women With Osteoporosis. Completed, enrolled 61 participants across 13 sites in 8 countries.

Detailed Summary

The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Denmark, Finland, Italy, Poland, Spain, Sweden
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 29, 2010
Enrollment StartOct 1, 2001
Primary CompletionMay 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.6 years ago

Interventions

Risedronatedrug

5 mg/day

Placebo/Risedronatedrug

placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8