NCT00426777已完成3 期
A Randomized, Single-blind, Placebo-controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate
CMX Research21 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 21
- 主要终点
- bone mineral density of the lumbar spine
研究概览
简要总结
Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.
详细描述
IV bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with LHRH agonists. However, it is yet to be determined if an oral bisphosphonate such as risedronate could offer the same benefits.
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
- Single (Participant)
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
- •Patients over 18 years of age.
- •Histologically confirmed diagnosis of prostate cancer without metastases.
- •Patient must have negative bone scan to rule out bone metastases.
- •Patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
- •Eastern Cooperative Oncology Group (ECOG) score of 0 -
- •Study medication must be started within 3 months of initiation of ADT.
- •Signed written informed consent.
排除标准
- •Prior ADT (greater than 3 months).
- •History of treatment with calcitriol or bisphosphonates.
- •Suppressive doses of thyroxine within the previous year.
- •Concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
- •Evidence of any of the following conditions per subject self-report or chart review:
- •Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if TSH is within normal reference range).
- •Paget's disease, Cushing's disease, hyperprolactinemia, chronic liver disease. Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.
- •Major surgery or significant traumatic injury occurring within 1 month prior to randomization.
- •Known hypersensitivity to leuprolide acetate or any of the components found in Eligard
- •Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
研究组 & 干预措施
risedronate
Active Comparator
干预措施: risedronate (Drug)
placebo
Placebo Comparator
干预措施: Control (Drug)
结局指标
主要结局
bone mineral density of the lumbar spine
时间窗: 12 months
次要结局
- overall safety(12 months)
研究者
研究点 (21)
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