At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,550 enrolled
Drug / intervention
Denosumabbiological
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 Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Denosumab for Osteopenia and Osteoporosis. Completed, enrolled 4,550 participants.
Detailed Summary
The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteopenia, Osteoporosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedAug 2007
Primary CompletionJul 2015
TodayJul 2026
First PostedAug 31, 2007
Enrollment StartAug 7, 2007
Primary CompletionJul 19, 2015
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 18.8 years ago
Interventions
Denosumabbiological
Administered by subcutaneous injection once every 6 months.