Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 114
- 主要终点
- Bone mineral density by test at 1 and 2 years
研究概览
简要总结
RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis.
PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.
详细描述
OBJECTIVES:
- Compare the change in bone mineral density in patients with prostate cancer who are receiving androgen-ablation therapy treated with calcium and cholecalciferol with or without conjugated estrogens and with or without risedronate.
- Compare the toxicity of these regimens in these patients.
- Compare the changes in bone markers in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare hot flashes in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to duration of therapy with luteinizing hormone-releasing hormone agonists (no more than 30 days vs 31 to 150 days vs 151 to 365 days vs more than 365 days). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.
- Arm II: Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.
- Arm III: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.
- Arm IV: Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.
Treatment in all arms continues for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: calcium carbonate (Dietary Supplement)
Arm I: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: cholecalciferol (Dietary Supplement)
Arm I: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: Estrogen Antagonists (Drug)
Arm I: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: placebo (Other)
Arm II: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: calcium carbonate (Dietary Supplement)
Arm II: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: cholecalciferol (Dietary Supplement)
Arm II: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: Estrogen Antagonists (Drug)
Arm II: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: risedronate sodium (Drug)
Arm III: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: calcium carbonate (Dietary Supplement)
Arm III: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: cholecalciferol (Dietary Supplement)
Arm III: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: Estrogen Antagonists (Drug)
Arm III: calcium + cholecalciferol + placebo + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate placebo daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: placebo (Other)
Arm IV: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: calcium carbonate (Dietary Supplement)
Arm IV: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: cholecalciferol (Dietary Supplement)
Arm IV: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: Estrogen Antagonists (Drug)
Arm IV: calcium + cholecalciferol + risedronate + estrogen
Patients receive oral calcium, oral cholecalciferol, low-dose oral conjugated estrogens, and oral risedronate daily.
Treatment in all arms continues for 2 years.
Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years.
Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
干预措施: risedronate sodium (Drug)
结局指标
主要结局
Bone mineral density by test at 1 and 2 years
时间窗: Up to 2 years
次要结局
- Toxicity questionnaires every 6 months(6 months)