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

NCT00925600 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 769

Last updated 2017-05-30

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Denosumab

Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg

BIOLOGICAL

Placebo

Prefilled syringe for subcutaneous (SC) injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2016-05-12
Completion
2016-05-12

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Greece
  • Hungary
  • India
  • Latvia
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • Slovakia
  • Slovenia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925600 on ClinicalTrials.gov