At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,139 enrolled
Drug / intervention
Alendronatedrug
Likely dose
Not stated in 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.
An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003
In Brief
A Phase 3 clinical trial evaluating Alendronate for Postmenopausal Osteoporosis. Completed, enrolled 1,139 participants across 25 sites in 10 countries.
Detailed Summary
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesArgentina, Brazil, Czechia, Denmark, Estonia, Hong Kong, Lithuania, Poland, Romania, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartNov 2012
Primary CompletionOct 2016
TodayJul 2026
First PostedAug 6, 2012
Enrollment StartNov 20, 2012
Primary CompletionOct 3, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.9 years ago
Interventions
Alendronatedrug
Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.