CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 781 enrolled
Drug / intervention
ibandronate [Bonviva/Boniva] +1 moredrug
Likely dose
ibandronate [Bonviva/Boniva] 3 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/NCT00551174
NCT00551174Phase 4Completed
CompareCT.gov

Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

Hoffmann-La Roche·interventional·Posted Oct 30, 2007·Updated Jul 22, 2011

In Brief

A Phase 4 clinical trial evaluating ibandronate [Bonviva/Boniva] for Post-Menopausal Osteoporosis. Completed, enrolled 781 participants across 39 sites in 15 countries.

Detailed Summary

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Menopausal Osteoporosis
CountriesAustralia, Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, South Africa, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 30, 2007
Enrollment StartOct 1, 2004
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 18.7 years ago

Interventions

ibandronate [Bonviva/Boniva]drug

3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

ibandronate [Bonviva/Boniva]drug

2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).