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Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

NCT00286091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1435

Last updated 2018-10-17

Study results available
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Summary

The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.

Conditions

  • Hormone Refractory Prostate Cancer

Interventions

BIOLOGICAL

Denosumab

Administered by subcutaneous injection

BIOLOGICAL

Placebo

Same volume subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-24
Primary Completion
2010-07-30
Completion
2014-04-09

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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 NCT00286091 on ClinicalTrials.gov