At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 160 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Ibandronate 150 mg orally once monthlyAI-extracted
Key inclusion· 3
- ✓Women aged 45–60 years
- ✓Postmenopausal status
- ✓Ambulatory (able to walk)
Key exclusion· 6
- ✕Vertebral fracture (excluding traumatic injury)
- ✕Low-trauma osteoporotic fracture in any bone
- ✕Breast cancer diagnosed within the past 20 years
- ✕Other malignancy diagnosed within the past 10 years (except basal cell cancer if successfully resected)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia
In Brief
A Phase 4 clinical trial evaluating Placebo and ibandronate [Bonviva/Boniva] for Post-Menopausal Osteopenia. Completed, enrolled 160 participants across 12 sites.
Detailed Summary
This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. 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--
ConditionsPost-Menopausal Osteopenia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2005
Enrollment StartDec 2005
Primary CompletionDec 2007
TodayJul 2026
First PostedAug 12, 2005
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.9 years ago
Interventions
Placebodrug
po monthly for 1 year
ibandronate [Bonviva/Boniva]drug
150mg po monthly for 1 year