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

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ClinicalTrials.gov Identifier: NCT00089661
Recruitment Status : Completed
First Posted : August 11, 2004
Results First Posted : January 26, 2010
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Low Bone Mineral Density Osteopenia Drug: Placebo Drug: AMG 162 / Denosumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : October 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089661


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089661     History of Changes
Other Study ID Numbers: 20040135
First Posted: August 11, 2004    Key Record Dates
Results First Posted: January 26, 2010
Last Update Posted: July 30, 2013
Last Verified: July 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
Metabolic 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