Hormone-receptor positive, postmenopausal primary breast cancer
Conditions
Interventions
An aromatase inhibitor, such as Anasrozole, Letrozole or Exemestane
An aromatase inhibitor + Risedronate, 17.5mg, orally, once a week
Sponsors
Graduate School of Medicine Kyoto University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)primary breast cancer (T1-2N0M0) 2)Post menopausal 3)ER+ve 4)HER2-ve 5)consitable eligible to aromatase inhibitors, i.e. ANA, LET and EXE 6) WBC>=3500 and <12,000, Hb>=9.0, PLT >=100,000, T-Bil <=2.0, AST, ALT<=100,CCR >=50ml/min, ECG normal 7) PS 0-1 8)Signed written informed consent
Exclusion criteria
Exclusion criteria: 1) Inflamatory breast cancer 2) Hypersensitivity to any reagents used in this trial. 3) Serious complications 4) Excess alcohol consumption 5) Habitual smoker 6) Family history of hip joint fracture 7) Active dental and/ or periodontal disease which requires treatment 8) Withdrawal of informed concent 9) Patients who are judged inappropriate for the clinical trial by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline on 18 month in bone mineral density | — |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline on 18 month in bone turnover markers | — |
Countries
Japan
Contacts
Public ContactTomoharu Sugie
Graduate School of Medicine Kyoto University Breast Surgery
Outcome results
None listed