At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,463 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
BA058 80 mcgfrom 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, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture
In Brief
A Phase 3 clinical trial evaluating Placebo, BA058 80 mcg, and 1 other intervention for Osteoporosis and Postmenopausal Osteoporosis. Completed, enrolled 2,463 participants across 28 sites in 10 countries.
Detailed Summary
The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal Osteoporosis
CountriesArgentina, Brazil, Czechia, Denmark, Estonia, Hong Kong, Lithuania, Poland, Romania, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedApr 2011
Primary CompletionOct 2014
TodayJul 2026
First PostedApr 27, 2011
Enrollment StartApr 1, 2011
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.2 years ago
Interventions
Placebodrug
Placebo 0 mcg subcutaneous daily
BA058 80 mcgdrug
BA058 80 mcg subcutaneous daily
teriparatidedrug
teriparatide 20 mcg subcutaneous daily