Try our beta test site

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00925600
First received: June 18, 2009
Last updated: June 27, 2016
Last verified: June 2016
  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.

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: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Subject incidence of lens opacification event development or progression by month 12, based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score. [ Time Frame: one year ]
    Lens opacification event development or progression


Other Outcome Measures:
  • Subject incidence of 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: one year ]
    Lens opacification event development or progression

  • Subject incidence of lens opacification event development or progression by month 6, based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score. [ Time Frame: 6 months ]
    Lens opacification event development or progression.

  • Subject incidence of a decrease from baseline BCVA as measured by a change of ≥ 10 letters on the ETDRS at 4 meters, at months, 3, 6, 9, and 12. [ Time Frame: one year ]
    Incidence of decreased best corrected visual acuity (BCVA)

  • Change in refraction needed to achieve BCVA at 3, 6, 9, and 12 as measured by change in sphere [ Time Frame: one year ]
    Change in refraction needed to achieve BCVA

  • Adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry). [ Time Frame: one year ]
    Safety as measured by adverse events and safety laboratory parameters

  • Subject incidence of confirmed lens opacification event development or progression by month 12, based on a change of ≥1.0 in P, ≥1.0 in C, or ≥0.7 in NO in the LOCSIII score. [ Time Frame: one year ]
    Confirmed lens opacification event development or progression. A confirmed lens opacification event development or progression is defined as 2 directly subsequent events per protocol assessments at the same location (P,C,NO) using LOCIII as above.


Estimated Enrollment: 760
Study Start Date: November 2009
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Arm B
Placebo subcutaneously on Day 1 and Month 6.
Biological: Placebo
Placebo administered subcutaneously on Day 1 and Month 6.

  Eligibility

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 ADT with 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925600

  Show 172 Study Locations
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
Study First Received: June 18, 2009
Last Updated: June 27, 2016

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
Lens Diseases
Eye Diseases
Androgens
Denosumab
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on March 24, 2017