A Phase III, Double-blind, Randomized, Parallel Group, Placebo-controlled Study of Oral Fosamax, 70 mg Once a Week, for the Prevention of Androgen Deprivation Bone Loss in Non-metastatic Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 182
- 主要终点
- Bone mineral density
研究概览
简要总结
Multi-center,double blind randomized phase III placebo controlled study in 250 men with histologically proven prostate cancer with out bone metastases who are beginning ADT therapy and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or placebo for one year.These men will be treated and follow up for one year,during which time changes in BMD, markers of bone resorption and formation will be monitored.All patients will receive calcium and vitamin D through out the study.
详细描述
This is a phase three multicentre, double blind, randomize parallel group, placebo-controlled study in 250 men with histologically proven cancer without bone metastases who are beginning ADT therapy and who will receive a concomitant treatment with either oral Fosamax 70 mg once a weak (n=125) or placebo (n=125) for one year. Changes in BMD, markers of bone absorption and formation are monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically proven, non-metastatic (M0) adenocarcinoma of the prostate.
- •Life expectancy of > 12 months.
- •Initiation of treatment with the luteinizing hormone-releasing hormone agonist (LHRH-a) Lupron no more than 15 days prior or 30 days following, baseline visit.
- •Requiring treatment with LHRH agonists for prostate cancer, for a duration of at least 12 months from baseline.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Prior to any study-specific procedures, subject (and/or their legally authorized representative) has voluntarily signed and dated an informed consent form.
排除标准
- •Bone Metastases Current or previous use with in past 12 months of bisphosphonate. Known hypersensitivity to LHRH. Hypocalcaemia. Severe renal impairment, Abnormal liver function, Hypothyroidism, Hyperthyroidism, Bilateral hip replacement.
- •Use of LHRH or anti-androgen medication within last 12 months. Abnormalities of esophagus which delay esophageal emptying. Inability to stand or sit upright for at least 30 minutes.
研究组 & 干预措施
placebo
干预措施: Alendronate (Drug)
结局指标
主要结局
Bone mineral density
时间窗: ONE YEAR
次要结局
- Blood and urine to check liver,kidney,thyroid functions. PSA and bone markers will also be checked(every 4 months)