A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months
研究概览
简要总结
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.
PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
详细描述
OBJECTIVES:
- Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate.
- Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
- Compare markers of bone formation and resorption in patients treated with these regimens.
- Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens.
- Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens.
- Compare the survival rate of patients treated with these regimens.
OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
- Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
干预措施: calcium gluconate (Drug)
Arm I
Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
干预措施: cholecalciferol (Dietary Supplement)
Arm I
Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
干预措施: calcium gluconate (Drug)
Arm I
Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
干预措施: zoledronic acid (Drug)
Arm II
Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
干预措施: cholecalciferol (Dietary Supplement)
结局指标
主要结局
Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months
时间窗: Bone scan taken at baseline and month 13
To assess bone density change as measured by dual-energy x-ray absorptiometry
次要结局
- Percentage Change in Lumbar Spine and Hip Bone Density as Measured by Plain Film X-rays of Lumbar Spine and Pelvis From Baseline to 13 Months(Lumbar spine and hip bone density taken at baseline and month 13.)
- Markers of Bone Formation and Resorption(Bone alkaline phosphatase taken at baseline, month 6 and month 13.)
- Incidence of Skeletal Events (Pathologic and Non-pathologic Bone Fractures, Spinal Cord Compression, Surgery to Bone, and Radiotherapy to Bone)(PSA taken at baseline, month 3, month 6, month 9, month 12 and month 13. CT scan of abdomen and pelvis taken at baseline and month 13. Serum testosterone, estradiol, parathyroid taken at baseline, month 6 and month 13.)
- Incidence of New or Progressive Bone Metastatic Disease(Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.)