CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,395 enrolled
Drug / intervention
ibandronate [Bonviva/Boniva] +2 moredrug
Likely dose
Ibandronate 2 mg intravenously every 2 months, 2.5 mg orally daily, or 3 mg intravenously every 3 monthsAI-extracted
Key inclusion· 3
  • ✓Women aged 55-80 years
  • ✓Postmenopausal for at least 5 years
  • ✓Ambulatory (able to walk)
Key exclusion· 5
  • ✕Malignant disease diagnosed within the previous 10 years, except basal cell cancer that has been successfully removed
  • ✕Breast cancer diagnosed within the previous 20 years
  • ✕Allergy to bisphosphonates
  • ✕Any prior treatment with intravenous bisphosphonate at any time

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

Search/NCT00048074
NCT00048074Phase 3Completed
CompareCT.gov

A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

Hoffmann-La Roche·interventional·Posted Oct 25, 2002·Updated Feb 3, 2016

In Brief

A Phase 3 clinical trial evaluating ibandronate [Bonviva/Boniva] for Post Menopausal Osteoporosis. Completed, enrolled 1,395 participants across 64 sites in 16 countries.

Detailed Summary

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Study Details

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

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2002
Enrollment StartJun 1, 2002
Primary CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 23.7 years ago

Interventions

ibandronate [Bonviva/Boniva]drug

2mg iv every 2 months

ibandronate [Bonviva/Boniva]drug

2.5mg po daily

ibandronate [Bonviva/Boniva]drug

3mg iv every 3 months