Breast Cancer
Conditions
Interventions
intake AI for 5 years and have subcutaneousinjection of denosumab every 6 months
only intake AI for 5 years
Sponsors
Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine
CTREC in Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria:
Exclusion criteria
Exclusion criteria: 1) Patients in whom distant metastasis was confirmed clinically or using imaging procedures at the time of case registration 2) Those with bilateral breast cancer 3) Those for whom postoperative hormonal therapy was started before consenting to study participation 4) Those who received endocrine therapy within 52 weeks before consenting to study participation 5) Those to whom bisphosphonate preparations were intravenously administered within 52 weeks before consenting to study participation 6) 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 7) Those with a history of malignant tumors other than breast cancer within 260 weeks before consenting to study participation 8) 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) 9) Others who are considered to be ineligible by the chief investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in the bone mineral density (BMD) for the lumbar vertebrae (L1-L4) on dual-energy X-ray absorptiometry (DXA) 12 months after the start of this study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of change in the BMD for the lumbar vertebrae (L1-L4) on DXA: After 2, 3, 4, and 5 years 2) Rate of change in the BMD for the femoral neck: After 12 months and 2/3/4/5 years 3) Rate of change in the BMD for the radius (an ultrasonic bone densimeter is used): After 2 and 4 weeks, every 4 weeks thereafter (for 2 years after registration)(only institutions in which ultrasonic bone densimeters are used) 4) Changes in Ca and bone metabolism markers (TRAP5b, bone-specific alkaline phosphatase (BSAP), blood pentosidine) 5) Appearance of morbid fracture within 3 years 6) Disease-free survival 7) Overall survival 8) Appearance (type, incidence) of adverse events (such as hypocalcemia and necrosis of the jaw) 9) Quality of life (QOL), Japanese version Euro-Qol (EQ-5D-5L) | — |
Countries
Japan
Contacts
Public ContactMidori Morita
Kyoto Prefectural University of Medicine Department of Endocrine and Breast Surgery
Outcome results
None listed