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
- Conditions
- Health Condition 1: null- CancerCataractLow Bone Mineral DensityOsteopeniaOsteoporosisProstate CancerHealth Condition 2: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2012/08/002905
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 760
Men more than 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
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 andor total hip andor 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 5ngmL at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject incidence of lens opacification event development or progression by month 12, based on a change of â?¥ 1.0 in P, â?¥ 1.0 in C, or â?¥ 0.7 in NO in the LOCS III score.Timepoint: Subject incidence of lens opacification event development or progression by month 12 exceeding a predefined level at any of 3 key lens locations using LOCS III score.
- Secondary Outcome Measures
Name Time Method Adverse event incidence and changes in safety analytes.Timepoint: [ Time Frame: One year ] [ Designated as safety issue: Yes ] <br/ ><br> <br/ ><br> <br/ ><br>;Subject incidence of lens opacification event development or progression by month 6, based on a change of â?¥ 1.0 in P, â?¥ 1.0 in C, or â?¥ 0.7 in NO in the LOCS III scoreTimepoint: [ Time Frame: One year ] [ Designated as safety issue: Yes ] <br/ ><br> <br/ ><br>
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