Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.
Phase 2
- Conditions
- rological Cancer with bone metastasis (Hormone resistant prostate cancer, Kidney cancer, urothelial cancer, kidney pelvis and ureteral cancer)
- Registration Number
- JPRN-UMIN000002291
- Lead Sponsor
- Department of Urology, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1.Experience of bisphosphonate administration (orally or iv) 2.Experience of radiation therapy to bone lesion within 3 months. 3.Experience of 89Sr injection 4.Patients suffering from Renal failure 5.Secnod cancer except above target urological cancer 6.Planned invasive dental therapy and under invasive dental therapy 7.Femail during pregnancy or with possible pregnancy. Female during lactation 8.Coexsistence with mental disorder or neurological symptom 9.disqualified by a medical doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Skeletal Related Events (SRE) incidence during study
- Secondary Outcome Measures
Name Time Method 1.SRE free survival 2.Change of bone-marker(urinary NTx, serum BAP, serum I-CTP) 3.Frequency of adverse events 4.Change of QOL score 5. Bone specific progression free survival 6.Change of BMD 7.Prastate-Specific Antigen (PSA) specific progression free survival 8.Overall survival