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 |
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.
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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