Trials / Completed
CompletedNCT00925600
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 769 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Male
- Age
- 30 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Denosumab | Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg |
| BIOLOGICAL | Placebo | Prefilled syringe for subcutaneous (SC) injection |
Timeline
- Start date
- 2009-11-30
- Primary completion
- 2016-05-12
- Completion
- 2016-05-12
- First posted
- 2009-06-22
- Last updated
- 2017-05-30
- Results posted
- 2017-05-30
Locations
172 sites across 18 countries: United States, Australia, Bulgaria, Canada, Czechia, France, Greece, Hungary, India, Latvia, Mexico, New Zealand, Poland, Russia, Slovakia, Slovenia, South Africa, Ukraine
Source: ClinicalTrials.gov record NCT00925600. Inclusion in this directory is not an endorsement.