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临床试验/NCT00063609
NCT00063609已完成4 期

The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy

Novartis Pharmaceuticals88 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年4月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
88
主要终点
Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.

研究概览

简要总结

The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate.

Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate.

Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.

次要结局

  • Percent changes in bone mineral density of the total hip
  • biochemical markers of bone turnover at one year

研究者

申办方类型
Industry

研究点 (88)

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