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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Supportive Care
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 12, 2016
- Biological: Denosumab
- Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
- Biological: Placebo
- Prefilled syringe for subcutaneous (SC) injection
Arms, Groups and Cohorts
- Placebo Comparator: Placebo
- Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
- Experimental: Denosumab
- Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
Clinical Trial Outcome Measures
- Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
- Time Frame: 12 months
- The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: Male
Minimum Age: 30 Years
Maximum Age: 120 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Provider of Information About this Clinical Study
- Overall Official(s)
- MD, Study Director, Amgen
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