breast cancer
Conditions
Interventions
period: 12months risedronate: 17.5mg/week letrozole: 2.5mg/day
period: 12months letrozole: 2.5mg/day
Sponsors
Hiroshima University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Postmenopausal women with hormonereceptor-positive early invasive breast cancer Patient who completed surgery, chemotherapy and radiotherapy as primary therapy within recent 12 weeks Eligible for letrozole as adjuvant therapy T-score is greater than -2.5 in lumbar spine (L1-L4) Patient who have no fracture in lumber spine and hip Patient who is not administered any medication that alter bone mineral density Proved to be eligible for administration of risedronate after consultation of dentistry Adequate general condition ECOG PS 0-2 Provided written Informed consent
Exclusion criteria
Exclusion criteria: Metastatic breast cancer Patient who have lumber spine or hip fracture Previous history of endocrine therapy for breast cancer within recent 12 months Patient who is not suitable condition for measurement of bone mineral density Patient who is planned to undergo dentistry surgery within 6 weeks Contraindication of study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of change from baseline to 12 months in lumbar spine (L1-L4) bone mineral density | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of change from baseline to 6 months in lumbar spine (L1-L4) bone mineral density rate of change from baseline to 12 months in total hip bone mineral density rate of change from baseline to 12 months in bone turnover markers | — |
Countries
Japan
Contacts
Public ContactShinsuke Sasada
Hiroshima University Hospital Breast Surgery
Outcome results
None listed