At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 394 enrolled
Drug / intervention
Denosumab (CP2) +1 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 Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Denosumab (CP2) and Denosumab (CP4) for Postmenopausal Osteoporosis. Completed, enrolled 394 participants across 23 sites in 4 countries.
Detailed Summary
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesCanada, Denmark, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedJun 2014
Primary CompletionJul 2015
TodayJul 2026
First PostedJun 6, 2014
Enrollment StartMay 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.1 years ago
Interventions
Denosumab (CP2)drug
Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
Denosumab (CP4)drug
Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.