At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 769 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 Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy
In Brief
A Phase 3 clinical trial evaluating Denosumab and Placebo for Cancer and 5 related conditions. Completed, enrolled 769 participants across 172 sites in 18 countries.
Detailed Summary
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Cataract, Low Bone Mineral Density, Osteopenia, Osteoporosis, Prostate Cancer
CountriesAustralia, Bulgaria, Canada, Czechia, France, Greece, Hungary, India, Latvia, Mexico, New Zealand, Poland, Russia, Slovakia, Slovenia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartNov 2009
Primary CompletionMay 2016
TodayJul 2026
First PostedJun 22, 2009
Enrollment StartNov 30, 2009
Primary CompletionMay 12, 2016
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 17.0 years ago
Interventions
Denosumabbiological
Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
Placebobiological
Prefilled syringe for subcutaneous (SC) injection