Status:
COMPLETED
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
Lead Sponsor:
Amgen
Conditions:
Cancer
Cataract
Eligibility:
MALE
30-120 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for at least 12 months
- Adequate visual accuracy allowing eye testing
- Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age
- Signed informed consent
Exclusion
- Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss
- Diagnosis of osteoporosis
Key Trial Info
Start Date :
November 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2016
Estimated Enrollment :
769 Patients enrolled
Trial Details
Trial ID
NCT00925600
Start Date
November 30 2009
End Date
May 12 2016
Last Update
May 30 2017
Active Locations (172)
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1
Research Site
Anaheim, California, United States, 92801
2
Research Site
Laguna Hills, California, United States, 92653
3
Research Site
Murrieta, California, United States, 92562
4
Research Site
San Diego, California, United States, 92103