MedTrace Logo

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy

NCT00556374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3420

Last updated 2023-07-27

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.

Conditions

Interventions

DRUG

Placebo

BIOLOGICAL

Denosumab

Administered as a subcutaneous injection

DRUG

Non-steroidal aromatase inhibitor therapy

An approved non-steroidal aromatase inhibitor therapy (eg, anastrazole) in the adjuvant setting

DRUG

Zoledronic Acid

5 mg zoledronic acid administered at a constant infusion rate

OTHER

Standard of Care

Standard of care (SoC) as recommended by the treating physician, depending on individual factors such as bone density, lifestyle recommendations by the Investigator such as diet, physical activities and sun exposure, as well as local treatment standards.

Sponsors & Collaborators

  • Austrian Breast and Colorectal Cancer Study Group

    collaborator UNKNOWN

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-18
Primary Completion
2014-10-07
Completion
2022-07-26

Countries

  • Austria
  • Sweden

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 NCT00556374 on ClinicalTrials.gov