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Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

NCT00091832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2014-01-28

Study results available
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Summary

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Conditions

Interventions

BIOLOGICAL

Denosumab

Denosumab administered by subcutaneous injection

DRUG

IV Bisphosphonates

Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2005-11-30
Completion
2006-10-31

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Entities

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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 NCT00091832 on ClinicalTrials.gov