NCT00181584已完成2 期
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.
研究概览
简要总结
The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.
详细描述
- Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.
- Zometa is administered intravenously over a 15 minute prior once in this one year study.
- All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
- All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Adenocarcinoma of the prostate
- •Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
- •Corrected serum calcium > 8.4mg/dl and < 10.6mg/dl
- •Serum creatinine < 2.0mg/dl
排除标准
- •History of bone metastases by bone scan
- •Treatment with bisphosphonate within one year
- •History of metabolic disease
- •Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year
研究组 & 干预措施
Group 1
Active Comparator
干预措施: Zoledronic acid (Drug)
Group 2
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.
时间窗: 3 years
次要结局
- To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo(3 years)
- to assess the safety and tolerability of zoledronic acid.(3 years)
研究者
Matthew R. Smith, MD, PhD
Professor of Medicine
Massachusetts General Hospital
研究点 (2)
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