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 |
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Recruitment Status :
Completed
First Posted : August 11, 2004
Results First Posted : January 26, 2010
Last Update Posted : July 30, 2013
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
- Study Details
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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
Genetics Home Reference related topics:
Breast cancer
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
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| 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
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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.
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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:
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Breast Cancer Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC osteopenia Low bone density |
Additional relevant MeSH terms:
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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 |