Clinical trial NCT00089661: AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Low Bone Mineral Density
Osteopenia
Keywords: Breast Cancer
Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC
osteopenia
Low bone density
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-08-11
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
timeFrame: 12 months
Secondary outcomes:
measure: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6
timeFrame: 6 months
measure: Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
timeFrame: 12 months
measure: Total Hip Bone Mineral Density Percent Change From Baseline at Month 6
timeFrame: 6 months
measure: Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
timeFrame: 12 months
measure: Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Fan M, Kim D. Effect of denosumab on bone mineral density in women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: subgroup analyses of a phase 3 study. Breast Cancer Res Treat. 2009 Nov;118(1):81-7. doi: 10.1007/s10549-009-0352-y. Epub 2009 Mar 24.
citation: Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Smith J, Fan M, Jun S. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol. 2008 Oct 20;26(30):4875-82. doi: 10.1200/JCO.2008.16.3832. Epub 2008 Aug 25.