A 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
Conditions:Prostate Cancer, Cancer, Cancer, Osteoporosis, Ocular, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology, Ophthalmology, Rheumatology
Healthy:No
Age Range:30 - 120
Updated:6/29/2016
Start Date:November 2009
End Date:May 2016

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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

This is a phase 3, randomized, 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.


Inclusion Criteria:

- Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral
orchiectomy or initiated ADT with 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 Criteria:

- 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
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