Evaluation of the utility of bone scan index (BSI) in the prediction of therapeutic effect of breast cancer patient with bone metastasis treated by zoledronic acid
Not Applicable
- Conditions
- Breast cancer patient with bone metastais
- Registration Number
- JPRN-UMIN000010749
- Lead Sponsor
- Gunma University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient with pregnancy, suspected pregnancy and breast feeding 2) Patient with difficulty in bone scintigraphy data analsysis due to the structural deformity or extraosseous uptake in bone scintigraphy 3) Patient with hypersensitivity to the element of zoredronic acid or bisphosphonate 4) Patient with renal dysfunction 5) Patient with active double cancer 6) Patient with severe underlying disease 7) Patient who need to be invasively treated due to infectious disorder of teeth and jawbone 8) Patient who underwent invasive dental treatment in the past three months 9) Patient who was treated by other bisphosphonate 10) Patient who was judged by medical doctor as inappropriate for this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The significant difference of the average rates of the BSI change before and after administration of zoledronic acid between two groups with and without SRE is evaluated using non-paired t test .
- Secondary Outcome Measures
Name Time Method (1) Correlation of BSI and bone metabolism markers (BAP, TRAP-5b, I-CTP) (2) Correlation of local BSI change rate and the height of vertebral bodies (3) Correlation SRE and BSI change rate in two groups with and without the effect of systemic therapy