Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer

Normal BMD means T score is ≥-1.0 for the lumbar vertebrae (L1-L4) and/or the femoral neck.

Inclusion criteria

Patients must meet all of the following items at the time of case registration:

• Patients with infiltrative breast cancer, aged ≥20 years, meeting the following definitions:

• Those pathologically diagnosed with stage I, II, or IIIA breast cancer (Cancer Management Regulations, 11th version)
• Those who underwent appropriate surgery, such as mastectomy and breast-preserving surgery
• Estrogen receptor (ER)- or progesterone receptor (PgR)-positive patients on immunohistochemical (IHC) staining
• Females meeting one of the following criteria for menopause:

• Those, aged ≥55 years, without menstruation
• Those, aged <55 years, with amenorrhea for ≥12 months, or those diagnosed with menopause by attending physicians based on the FSH and estradiol levels
• Those who underwent bilateral oophorectomy
• Patients in whom the BMD for the lumbar vertebrae (L1-L4) on DXA before the start of this study is ≥-1.0SD of the mean value of young adult females (YAM), and the BMD for the femoral neck is ≥-1.0SD of YAM
• Patients without lumbar vertebral or femoral fracture
• Those with an ECOG PS of 0-2
• Those with adequate organ functions (laboratory data within 4 weeks before case registration)

• Leukocyte count, ≥3,000/mm3 or Neutrophil count, ≥1,500/mm3
• AST, ALT, ≤1.5-fold of the upper limit of the institutional reference range
• Serum creatinine, ≤1.5-fold of the upper limit of the institutional reference range
• Case registration should be performed before the following point:Twelve weeks after the completion of surgery or postoperative chemotherapy (The completion of chemotherapy refers to the completion of the final course, involving the recovery phase.)
• Patients with an interval of ≥4 weeks after the discontinuation of therapy with bisphosphonates (oral preparations), estrogen preparations, raloxifene, calcitonin preparations, vitamin K preparations, active vitamin D preparations, or ipriflavone preparations, which influence bones
• Those from whom written informed consent regarding study participation was obtained

Exclusion criteria

Whether each patient meets any of the following items must be checked on case registration:

• Patients in whom distant metastasis was confirmed clinically or using imaging procedures at the time of case registration
• Those with bilateral breast cancer
• Those for whom postoperative hormonal therapy was started before consenting to study participation
• Those who received endocrine therapy within 52 weeks before consenting to study participation
• Those to whom bisphosphonate preparations were intravenously administered within 52 weeks before consenting to study participation
• Those with the following diseases that may affect DXA

• Severe scoliosis, immobility, hyperostosis or osteosclerosis of the lumbar vertebrae, calcification of the abdominal aorta, and vertebral disease
• Those with a history of malignant tumors other than breast cancer within 260 weeks before consenting to study participation
• Those with dental diseases, such as infectious diseases of the teeth or jaw and tooth trauma. Those for whom tooth or jaw surgery is scheduled within 6 weeks after consenting to study participation (tooth extraction, implantation)
• Others who are considered to be ineligible by the chief investigator