Breast cancer patient with bone metastais
Conditions
Interventions
None listed
Sponsors
Gunma University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patient who undewent bone scintigraphy 2) Patient with more than 1 bone metastasis 3) Patient older than 20 years old 4) Patients with Performance Status (PS, ECOG classification) 0 to 2 (If PS3 and 4 is due to only bone metastasis, it can be included ) 5) Breast cancer patient with scheduled Zoledronic acid treatment 6) Patient with preserved major organ function as shown below, WBC: more than 3,000/mm3 or Neutrophil more than 1,500/mm3 Hb (Hemoglobin): more than 9.0g Plt (Platelet): more than 100,000/mm3 T-Bil (Total serum bilirubin): Less than 1.5 times of normal limit in each institute AST and ALT: Less than 2.5 times of normal limit in each institute Serum creatinine: less than 2.0mg/dL Serum calcium: more than 8.0mg/dL (and less than 12.0mg/dL) Corrected Calcium (mg/dL)=measured serum calcium - Serum albumin (g/gL)+4 7) Patients with no abnormality in oral investigation 8) Patients who offered written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Outcome results
None listed