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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cancer, Cataract, Low Bone Mineral Density, Osteopenia, Osteoporosis, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00925600

Run by

Amgen

People needed

769

Starts

2009-11-30

Expected to finish

2016-05-12

Last updated by the study team

2017-05-30

Who can join

Age: 30 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Laguna Hills, California, United States
• Research Site — Murrieta, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Luis Obispo, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Englewood, Colorado, United States
• Research Site — Middlebury, Connecticut, United States
• Research Site — New Britain, Connecticut, United States
• Research Site — Trinity, Florida, United States
• Research Site — Coeur d'Alene, Idaho, United States
• Research Site — Greenwood, Indiana, United States
• Research Site — West Des Moines, Iowa, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Annapolis, Maryland, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Greenbelt, Maryland, United States
• Research Site — Grand Rapids, Michigan, United States
• Research Site — Sartell, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Missoula, Montana, United States
• Research Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.