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)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy397405.aspx
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Salem |
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State:
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VA |
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| Conditions: |
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Cancer - Cataract - Low Bone Mineral Density - Osteopenia - Osteoporosis - Prostate Cancer |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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Research Site
Salem, VA
United States
Primary Contact:
Amgen Call Center
Phone: 866-572-6436 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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