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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00089661
First received: August 9, 2004
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.


Enrollment: 252
Study Start Date: October 2004
Estimated Study Completion Date: May 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
Genders 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
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
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Global Development Leader, Amgen Inc.
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: January 20, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013