Phase 3
N=252
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
Breast Cancer · Low Bone Mineral Density · Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT00089661 ↗Enrolled (actual)
252
Serious AEs
12.0%
Results posted
Jan 2010
Primary outcome: Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 — 4.8; -.7 Percent Change from Baseline — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); AMG 162 / Denosumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 |
4.8; -.7 | <0.0001 sig |
| SECONDARY Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6 |
3.7; -.6 | — |
| SECONDARY Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 |
3.1; -.7 | — |
| SECONDARY Total Hip Bone Mineral Density Percent Change From Baseline at Month 6 |
2.3; -.4 | — |
| SECONDARY Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12 |
1.9; -.6 | — |
| SECONDARY Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6 |
1.2; -.9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00089661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.