AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

September 20, 2018 updated by: Amgen

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study
  • All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
  • Female > 18 years of age
  • ECOG Performance status 0 and 1
  • Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5
  • Subject is willing and able to provide signed consent before any study-specific procedure

Other criteria also apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
Experimental: AMG 162 / Denosumab
Drug: AMG 162 / Denosumab
60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
12 months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
12 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6
Time Frame: 6 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
6 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 6
Time Frame: 6 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
6 months
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6
Time Frame: 6 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2004

Primary Completion (Actual)

May 11, 2007

Study Completion (Actual)

May 27, 2009

Study Registration Dates

First Submitted

August 9, 2004

First Submitted That Met QC Criteria

August 10, 2004

First Posted (Estimate)

August 11, 2004

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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