Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

Phase 3

Completed

• Conditions: Cataract; Low Bone Mineral Density; Osteopenia; Osteoporosis; Prostate Cancer; Cancer
• Interventions: Biological: Denosumab; Biological: Placebo

• Registration Number: NCT00925600
• Lead Sponsor: Amgen

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 to androgen deprivation therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-22
• Study Start: 2009-11-30
• Primary Completion: 2016-05-12
• Study Completion: 2016-05-12
• Status Verified: 2017-04
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 769

Inclusion Criteria

• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab	Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
Placebo	Placebo	Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Lens Opacification Event Development or Progression by Month 12	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.

Trial Locations

Locations (1)

Research Site; 🇺🇦 Zaporizhzhya, Ukraine