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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 - NCT00925600-(Clinical Trial 397405)



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City:  Salem
State:  
VA
Zip Code:
Conditions: Cancer - Cataract - Low Bone Mineral Density - Osteopenia - Osteoporosis - Prostate Cancer
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - Men >=30 years of age with non-metastatic prostate cancer - Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and is expected to continue on ADT for at least 12 months - ECOG score (0,1 or 2) - Baseline BCVA of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS charts at 4 meters in one eye with a natural, intact lens - Bone Mineral Density (BMD) requirements: If <70 years: BMD T-score at the lumbar spine, total hip, or femoral neck >= -2.5 and <=-1.0 (osteopenia) If >= 70 years of age: BMD T-score at lumbar spine and total hip and femoral neck >= -2.5 At least 2 evaluable lumbar vertebrae Exclusion Criteria: - Screening LOCS III grade of >=3.5 for posterior subcapsular cataract, >= 4.0 for cortical cataract, or >= 4.5 for nuclear opalescence - Bone Mineral Density (BMD) T-score< -2.5 at lumbar spine and/or total hip and/or femoral neck ("osteoporosis") - evidence of distant metastases - Known osteonecrosis of the jaw (ONJ) - Unstable system disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization - Incisional eye surgery in both eyes or cataract surgery in both eyes - Current administration of IV bisphosphonates - PSA > 5ng/mL at screening.
Study is available at: Research Site
Salem, VA
United States

Primary Contact:
Amgen Call Center
Phone: 866-572-6436
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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