A randomized phase II study of efficacy of risendronate for the prevention of letrozole-induced bone mineral loss in post-menopausal breast cancer patients
Phase 2
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000005568
- Lead Sponsor
- Hiroshima University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rate of change from baseline to 12 months in lumbar spine (L1-L4) bone mineral density
- Secondary Outcome Measures
Name Time Method 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