An Open-Label, Randomized, Multicentre Study to Evaluate the Efficacy of Two Zoledronic Acid Schedules on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
研究概览
简要总结
The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving.
After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Histologically confirmed diagnosis of carcinoma of the prostate
- •No distant metastases
- •Patients must be candidates for androgen deprivation therapy (ADT)
- •Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible
排除标准
- •Patients with normal BMD at trial entry
- •Patients who received any prior bisphosphonate therapy in the past 12 months
- •Treatment with anti-androgen mono- or combination therapy
- •Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
- •Patients who have received prior treatment with systemic corticosteroids within the past 12 months
- •Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
- •Patients with any prior treatment for osteoporosis
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
次要结局
- To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
- The percent change in BMD of the total hip following one year of therapy and the forearm following one year of therapy. This will be carried out at a limited number of centres.
- Quality of life following one year of therapy.
- Various biochemical markers of bone resorption (N-telopeptide, NTX, C-telopeptide, CTX, TRACP, PINP) and bone formation (bone alkaline phosphatase, BAP) during one year of therapy. This will be carried out at a limited number of centres.
- Percentage of and rate of vertebral and hip fractures.
- Safety and tolerability