Health Condition 1: null- Cancer Cataract Low Bone Mineral Density Osteopenia Osteoporosis Prostate Cancer Health Condition 2: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Active Comparator: Arm A
Denosumab 60 mg subcutaneously on Day 1 and Month 6: Biological: Denosumab
Denosumab 60 mg is administered subcutaneously on Day 1 and Month 6.
Control Interv
Sponsors
Amgen Technology Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Adverse event incidence and changes in safety analytes.Timepoint: [ Time Frame: One year ] [ Designated as safety issue: Yes ] ;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 ] | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States of America
Contacts
Public ContactDr Veena Jaguste
Amgen Technology Pvt. Ltd
Outcome results
None listed