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临床试验/JPRN-UMIN000006736
JPRN-UMIN000006736已完成2 期

A multicenter, open-label trial to evaluate the effects of zoledronic acid on circulating tumor cells in patients with castration resistant prostate cancer (CRPC) with bone metastasis. - CRPC with BM/ZOL-CTC Study

Teikyo University, School of Medicine Department of Urology0 个研究点目标入组 20 人开始时间: 2011年11月16日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
ot applicable 至 ot applicable(—)
性别
Male

入选标准

  • 未提供

排除标准

  • 1) Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid 2) Prior treatment with antiresorptive agent (e.g. RANK ligand inhibitor) 3) Patients with proven brain metastases 4) History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism 5) Patients with need of treatment for osteoporosis (defined according to DXA, lumber spine BMD T-Score less than 2.5). 6) Patients with NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG 7) Patients with clinically significant ascites 8) Known hypersensitivity to zoledronic acid or other bisphosphonates 9) Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl) or more than 12.0 mg/dl 10) Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for more than 5 yrs. 11) Current active dental problems including infection of the teeth or jawbone 12) Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants) 13) Any change in therapy within the last 2 months (Chemotherapy, change in hormonal therapy) 14) Known history or present abuse of alcohol or drugs 15) Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment

研究者

发起方
Teikyo University, School of Medicine Department of Urology

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