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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00925600
• Date of registration: 18/06/2009
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
• Scientific 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
• Date of first enrolment: November 30, 2009
• Target sample size: 769
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00925600
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Bulgaria, Canada, Czech Republic, Czechia, France, Greece, Hungary, India, Latvia, Mexico, New Zealand, Poland, Russian Federation, Slovakia, Slovenia, South Africa, Ukraine, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 120 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cancer

Cataract

Low Bone Mineral Density

Osteopenia

Osteoporosis

Prostate Cancer

Intervention(s)

Biological: Denosumab

Biological: Placebo

Primary Outcome(s)

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

Secondary ID(s)

20080560

2009-012076-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00925600