At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 311 enrolled
Drug / intervention
denosumab +1 morebiological
Likely dose
denosumab 60 mgfrom 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 Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density
In Brief
A Phase 3 clinical trial evaluating denosumab for Low Bone Mineral Density and 2 related conditions. Completed, enrolled 311 participants.
Detailed Summary
The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Bone Mineral Density, Osteopenia, Osteoporosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedAug 2007
Primary CompletionMar 2008
Study CompletionMar 2009
TodayJul 2026
First PostedAug 13, 2007
Enrollment StartMay 1, 2007
Primary CompletionMar 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.9 years ago
Interventions
denosumabbiological
60 mg denosumab in 1mL
denosumabbiological
60 mg denosumab in 1mL