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Study Complete
Sponsor ID
20080560

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

Sponsor ID
20080560
Clinicaltrials.gov ID
NCT00925600
EUCTIS ID
N/A
EudraCT ID
2009-012076-26
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
769
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of lens opacification event development or progression by month 12, based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score.

Timeframe: one year

Secondary Outcome Measures
Not Available

Locations

Location
Status
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Location
Research Site
Albany, NY, United States, 12208
Status
Completed
Location
Research Site
Anaheim, CA, United States, 92801
Status
Completed
Location
Research Site
Austin, TX, United States, 78759
Status
Completed
Location
Research Site
Bentleigh East, VIC, Australia, 3165
Status
Completed
Location
Research Site
Cincinnati, OH, United States, 45212
Status
Completed
Location
Research Site
Dallas, TX, United States, 75231
Status
Completed
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Study Info
Age
30 - 120 Years
Condition
  • Cancer - Other
    • Show more
  • Cataract
  • Bone Loss
  • Bone Pain
  • Osteoporosis
  • Prostate Cancer
    • Sex
    Assigned Male at Birth
    Trial Dates
    Nov 2009 - May 2016
    Inclusion and Exclusion Criteria
    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