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Study Complete
Sponsor ID
20040135

AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

Sponsor ID
20040135
Clinicaltrials.gov ID
NCT00089661
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
252
Additional Study Details

Protocol Summary

Primary Outcome Measures

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

Timeframe: 12 months

Secondary Outcome Measures

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6

Timeframe: 6 months

Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

Timeframe: 12 months

Total Hip Bone Mineral Density Percent Change From Baseline at Month 6

Timeframe: 6 months

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

Timeframe: 12 months

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6

Timeframe: 6 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Breast Cancer
    • Show more
  • Bone Loss
  • Bone Pain
    • Sex
    Assigned Female at Birth
    Trial Dates
    Oct 2004 - May 2007
    Inclusion and Exclusion 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.