| Exclusion Criteria: | 1) Concurrent systemic anti-neoplastic therapy including biologic therapy trastuzumab, other than aromatase inhibitor therapy.
2) Evidence of distant metastases.
3) Lumbar spine, total hip or femoral neck BMD with T-score < -2.5.
4) Prior history of non-traumatic fracture or vertebral fracture after the age of 25.
5) Height, weight, and girth which may preclude accurate DXA measurements or less than 2 evaluable lumbar vertebrae (L1-L4) for DXA measurement.
6) Current administration of oral bisphosphonates, or previous use as follows: (1) >/= 3 years continuously; or (2) > 3 months but < 3 years (eligible if patient has a 1 year washout prior to randomization).
7) Administration of IV bisphosphonates, fluoride, strontium ranelate, sumarium-153 or gallium nitrate within the past 5 years.
8) Prior use of raloxifene, estrogen, calcitonin, recombinant parathyroid hormone within 6 weeks of randomization.
9) Prior administration of an OPG construct (i.e. AMGN-0007, Fc-OPG) or AMG 162.
10) Concurrent chronic corticosteroid therapy or pulse corticosteroid therapy (topical, inhaled, or nasal steroids are allowed).
11) Recurrence of the primary malignancy.
12) Diagnosis of any second non-breast malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
13) Evidence of any of the following conditions per subject self-report or chart review: (1) Current hyper- or hypothyroidism (stable on thyroid replacement thrpy allowed, if TSH is within normal range); (2) Paget's disease, Cushing's disease, hyperprolactinemia, or chronic liver disease; (3) Unstable systemic disease including active infection, rheumatoid arthritis, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 mths prior to randomization; (4) Major surgery, or significant traumatic injury occurring within 4 weeks prior to randomization.
14) By patient self-report or review of the chart: Known HIV, HCV or chronic Hepatitis B infection.
15) Inadequate organ function as defined by the following criteria: (1) Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) >2.5 x central laboratory-upper limit of normal (CL-ULN) (NCI CTC grade >1); (2) Total serum bilirubin >1.5 x ULN (NCI CTC grade >1); (3) Absolute neutrophil count (ANC) <1.5 x 10*9/L; (4) Platelets <100 x 10*9/L; (5) Hemoglobin <10.0 g/dL; (6) Serum calcium >11.50 mg/dL (2.9 mmol/L) or <8.0 mg/dL (2.0 mmol/L); (7) Serum creatinine >2.0 x ULN (178 umol/L).
16) iPTH > 1.5 x ULN.
17) 25-hydroxy Vitamin D < 12 ng/mL
18) Any organic or psychiatric disorder which, in the opinion of the investigator, may prevent the subject from completing the study or interfere with the interpretation of the study results.
19) Currently enrolled in or has not yet completed at least 4 weeks washout since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
20) Known sensitivity to mammalian derived products.
21) Subjects who are pregnant, breast-feeding, or plan to become pregnant during the course of the study. All subjects with reproductive potential must have a negative pregnancy test within seven days before randomization.
22) Self-reported drug or alcohol abuse within the previous 24 weeks before study enrollment.
23) Any kind of disorder that compromises her ability to give written informed consent and/or comply with study procedures.
24) NONE of the 3 bone regions (lumbar spine, total hip, femoral neck) can be in the osteoporotic range: L-spine Hologic < 0.772g/cm^2, GE Lunar < .880g/cm^2. Total Hip Hologic < 0.637g/cm^2, GE Lunar < 0.700 g/cm^2. Femoral Neck Hologic < 0.572 g/cm^2, GE Lunar < 0.680 g/cm^2 |