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

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Low Bone Mineral Density Osteopenia	Drug: Placebo Drug: AMG 162 / Denosumab	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.
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.
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.
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.
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.


Enrollment:	252
Study Start Date:	October 2004
Study Completion Date:	December 2009
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089661

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Smith J, Fan M, Jun S. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol. 2008 Oct 20;26(30):4875-82. doi: 10.1200/JCO.2008.16.3832. Epub 2008 Aug 25.

Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Fan M, Kim D. Effect of denosumab on bone mineral density in women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: subgroup analyses of a phase 3 study. Breast Cancer Res Treat. 2009 Nov;118(1):81-7. doi: 10.1007/s10549-009-0352-y. Epub 2009 Mar 24.


Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00089661 History of Changes
Other Study ID Numbers:	20040135
Study First Received:	August 9, 2004
Results First Received:	December 22, 2009
Last Updated:	July 23, 2013

Keywords provided by Amgen:


Breast Cancer Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC osteopenia Low bone density

Additional relevant MeSH terms:


Breast Neoplasms Bone Diseases, Metabolic Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bone Diseases Musculoskeletal Diseases Denosumab	Aromatase Inhibitors Bone Density Conservation Agents Physiological Effects of Drugs Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2017