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