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临床试验/NCT00816452
NCT00816452已完成不适用

Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.

Sanofi1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sanofi
入组人数
180
试验地点
1
主要终点
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

研究概览

简要总结

Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.

Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

Secondary objectives:

To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.

To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Man with Prostate Cancer
  • Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
  • Osteopenia/osteoporosis proven by bone density test.

排除标准

  • Creatinine clearance < 30ml/min
  • Hypercalcemia
  • Actual treatment by Bisphosphonate or steroids
  • Hypersensibility to Bisphosphonate or any contraindication to its use.
  • Metastatic prostate Cancer
  • Patients not suitable for compliance.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

结局指标

主要结局

To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

时间窗: 6 months

次要结局

  • To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.(6 months)
  • To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics(6 months)
  • To evaluate incidence of osteopenia/osteoporosis in this study population.(6 months)

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (1)

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