At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 140 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
ibandronate 150mgfrom 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.
A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women
In Brief
A Phase 4 clinical trial evaluating Placebo and ibandronate for Postmenopausal Osteoporosis. Completed, enrolled 140 participants across 15 sites.
Detailed Summary
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesFinland
CollaboratorsGlaxoSmithKline
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedOct 2007
Primary CompletionMay 2009
TodayJul 2026
First PostedOct 17, 2007
Enrollment StartMay 1, 2006
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 18.7 years ago
Interventions
Placebodrug
po monthly for 12 months
ibandronatedrug
150mg po monthly for 12 months