The efficacy of the use of denosumab in the prevention of aromatase inhibitor-induced bone loss in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000013863
- Lead Sponsor
- Department of Endocrine and breast cancer, Kyoto Prefectural University of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Diagnosis of clinical or radiological disant metastasis before inclusion 2) Invasive bilateral breast cancer 3) Received prior treatment with intravenous bisphosphonates within the past 12 months 4) Following diseases which may interfere with DXA scan such as severe scoliosis, vertebral diseases 5) Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants) 6) Other conditions judged as inappropriate for the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the percent change in lumbar spine(L1-L4)BMD from baseline to 12 months
- Secondary Outcome Measures
Name Time Method 1) the percent change in lumbar spine(L1-L4)BMD from basebaline to 6 months,two years, three years, four years and five years. 2) the percent change in total hip BMD from basebaline to 6 months, 12 months, two years, three years, four years and five years. 3) To identify changes in serum markers of bone turnover, TRACP-5b and BAP, from basebaline to 6 months, 12 months, two years, three years, four years and five years. 4) Disease-free survival 5) Bone metastasis-free survival 6) Overall survival 7) Distant recurrence-free survival