AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00089661
First received: August 9, 2004
Last updated: July 23, 2013
Last verified: July 2013
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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:
Genetics Home Reference 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 ] [ 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 |
| 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) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00089661
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089661
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
| 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 |
| 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 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 September 27, 2016