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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
| 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
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
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 Breast Diseases Neoplasms Neoplasms by Site Skin Diseases |
Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on February 27, 2015