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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00925600
First Posted: June 22, 2009
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose
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.

Condition Intervention Phase
Cancer Cataract Low Bone Mineral Density Osteopenia Osteoporosis Prostate Cancer Biological: Denosumab Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Participants With Lens Opacification Event Development or Progression by Month 12 [ Time Frame: 12 months ]
    The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.


Other Outcome Measures:
  • Percentage of Participant With Lens Opacification Event Development or Progression by Month 12 Based on a Change of ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III Score [ Time Frame: 12 months ]
    The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III score from baseline.

  • Percentage of Participants With Lens Opacification Event Development or Progression by Month 6 [ Time Frame: 6 months ]
    The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 6 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.

  • Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12 [ Time Frame: 12 months ]

    The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity.

    Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline. A confirmed lens opacification event development or progression was defined as 2 directly subsequent events per protocol assessments at the same location (P, C, NO) using LOCS III as above.


  • Percentage of Participants With a Decrease From Baseline in Best Corrected Visual Acuity (BCVA) of ≥ 10 Letters [ Time Frame: Baseline and Months 3, 6, 9 and 12 ]

    The best corrected visual acuity (BCVA) is the best vision one can achieve with correction (such as eye glasses) as measured on an eye chart. BCVA was assessed by a trained ophthalmologist using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at 4 meters. The modified University of Crete ETDRS chart was used in Ukraine, Greece, Russia and Bulgaria, which do not use the Roman alphabet. The 2000 series revised ETDRS chart was used to assess the change in all other countries.

    The letter score was calculated based on the number of letters that were correctly identified; higher letter scores correspond to better visual acuity.


  • Change From Baseline in Refraction Needed to Achieve BCVA [ Time Frame: Baseline and months 3, 6, 9, and 12 ]
    Refraction error was measured using a phoropter. The change from baseline in spherical refraction error needed to achieve BCVA is reported.

  • Number of Participants With Adverse Events [ Time Frame: 12 months ]

    Adverse events (AEs) were assessed for severity by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) severity grading scale, version 3.0, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 =Life-threatening AE and Grade 5 = Death due to AE.

    Treatment-related AEs (TRAEs) include only events for which the investigator indicated there was a reasonable possibility they may have been caused by the study drug.



Enrollment: 769
Actual Study Start Date: November 30, 2009
Study Completion Date: May 12, 2016
Primary Completion Date: May 12, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
Biological: Placebo
Prefilled syringe for subcutaneous (SC) injection
Experimental: Denosumab
Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
Biological: Denosumab
Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
Other Name: Prolia®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925600


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Laguna Hills, California, United States, 92653
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Denver, Colorado, United States, 80204
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Ivanovo, Russian Federation, 153013
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Nizhny Novgorod, Russian Federation, 603126
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Rostov-na-Donu, Russian Federation, 344022
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Bratislava, Slovakia, 851 05
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Celje, Slovenia, 3000
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Ljubljana, Slovenia, 1525
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Slovenj Gradec, Slovenia, 2380
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Paarl, Western Cape, South Africa, 7646
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George, South Africa, 6530
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Kempton Park, South Africa, 1619
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Port Elizabeth, South Africa, 6001
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Tygerberg, South Africa, 7505
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Chernivtsi, Ukraine, 58002
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Dnipropetrovsk, Ukraine, 49005
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Kharkiv, Ukraine, 61037
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Kyiv, Ukraine, 02125
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Uzhgorod, Ukraine, 88000
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Zaporizhzhya, Ukraine, 69600
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00925600     History of Changes
Other Study ID Numbers: 20080560
2009-012076-26 ( EudraCT Number )
First Submitted: June 18, 2009
First Posted: June 22, 2009
Results First Submitted: April 19, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by Amgen:
Lens Opacification
Bone Loss
Androgen Deprivation Therapy
Non-metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Osteoporosis
Cataract
Bone Diseases, Metabolic
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Lens Diseases
Eye Diseases
Androgens
Denosumab
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents