At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,262 enrolled
Drug / intervention
Denosumab +2 moredrug
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.
A Randomized, Double-Blind, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of Denosumab in Japanese Osteoporotic Subjects With Prevalent Fragility Vertebral Fracture(s)
In Brief
A Phase 3 clinical trial evaluating Denosumab, Placebo, and 1 other intervention for Osteoporosis. Completed, enrolled 1,262 participants across 4 sites.
Detailed Summary
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedMay 2008
Primary CompletionJun 2012
Study CompletionJul 2012
TodayJul 2026
First PostedMay 20, 2008
Enrollment StartMay 1, 2008
Primary CompletionJun 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 18.1 years ago
Interventions
Denosumabdrug
Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
Placebodrug
Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
Alendronate sodium hydratedrug
Oral tablet once a week for 24 months