UMIN ID: UMIN000002291
Registered date:10/08/2009
Efficacy and Safety of Zoledronic acid on urological cancer patients with bone metastasis: a phase II clinical study.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Urological Cancer with bone metastasis (Hormone resistant prostate cancer, Kidney cancer, urothelial cancer, kidney pelvis and ureteral cancer) |
| Date of first enrollment | 2007/10/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 4mg Zoledronic Acid will be administered every 4 weeks for 96 weeks(24 times) |
Outcome(s)
| Primary Outcome | Total Skeletal Related Events (SRE) incidence during study |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Department of Urology, Graduate School of Medical Sciences, Kyushu University |
|---|---|
| Secondary Sponsor | Kyushu Univ UOEH Harasanshin Hospital Kurume Univ Saga Univ Nagasaki Univ Nagasaki Municipal Hospital Nagasaki Genbaku Hospital Oita Univ Miyazaki Univ Kagoshima Univ Ryukyu Univ Hokkaido Univ Nagasaki Med. Center |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akira Yokomizo |
| Address | 3-1-1, Higashi-ku, Fukuoka, Japan |
| Telephone | +81-92-642-5603 |
| yokoa@uro.med.kyushu-u.ac.jp | |
| Affiliation | Graduate School of Medical Sciences, Kyushu University Department of Urology |
| scientific contact | |
| Name | Seiji Naito |
| Address | Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan |
| Telephone | +81-92-642-5603 |
| Affiliation | Graduate School of Medical Sciences, Kyushu University Department of Urology |