At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 384 enrolled
Drug / intervention
Denosumabdrug
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.
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Denosumab for Cancer and 4 related conditions. Completed, enrolled 384 participants across 74 sites in 6 countries.
Detailed Summary
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer, Tumors
CountriesCanada, Finland, Hungary, Mexico, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionMay 2012
TodayJul 2026
First PostedFeb 6, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMay 3, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.4 years ago
Interventions
Denosumabdrug
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18