Prevention of Osteoporosis in Men With Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Our primary outcome variable will be change in spine bone mineral density over one year and change during the second year (or both years).
研究概览
简要总结
The overall goal of this proposal is to determine the effectiveness and safety of once weekly alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with prostate cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following termination of therapy after one year.
详细描述
While osteoporosis in women is recognized as a major public health problem, osteoporosis in men also has a profound clinical impact. Men over the age of 75 who sustain hip fractures have a higher mortality than women of the same age (30% versus 9%). Hip fractures in men account for one-third of all hip fractures. In 1995, male osteoporosis accounted for $2.7 billion in health care costs -- nearly one-third of the overall cost of osteoporosis. Alendronate has been shown to improve bone mass and decrease vertebral fractures in men with osteoporosis.
Prostate cancer is the most common visceral malignancy and the second leading cause of death in American men. Almost all men who progress to late stage disease are treated with androgen deprivation therapy for life, resulting in a 5-fold increased risk of hip fractures and a 13-fold increased risk of all osteoporosis fractures. Several studies suggest the merit of inducing androgen deprivation much earlier in the course of therapy for prostate cancer. It is therefore quite likely that androgen deprivation strategies will be employed with increasing frequency in patients with less advanced disease, resulting in longer life expectancy but greater bone loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Men age 18 and older with stage Do prostate cancer (as defined by asymptomatic disease, rising PSA, and negative bone scans) following attempted curative surgery and/or radiation
- •Androgen deprivation therapy (gonadotropin releasing hormone agonists, lutenizing hormone releasing hormone agonists, testosterone antagonists, orchiectomy) for at least 6 months for treatment of prostate cancer
排除标准
- •History of any illness known to affect bone and mineral metabolism (renal failure, hepatic failure, Paget's disease, osteogenesis imperfecta, osteomalacia)
- •Non-prostate cancer diagnosed within last 5 years (treated superficial basal and squamous cell carcinoma excepted)
- •Hyperparathyroidism
- •Malabsorption
- •Treatment with medications known to affect bone metabolism (chronic high-dose corticosteroid therapy for at least 6 months, thyroid hormone with TSH <0.1 micrograms, antiseizure medications)
- •Active peptic ulcer
- •Inability to sit upright or stand for at least 30 minutes
- •Kidney stones in the past 5 years
- •24-hour urine calcium value >400 mg/24 hours
- •Esophageal stricture or achalasia
- •Hyperthyroidism
- •Evidence of chronic liver disease (including alcoholism)
- •Treatment within past year for osteoporosis (calcitonin, fluoride, bisphosphonates)
- •History of atraumatic fractures, previous fracture due to a fall from standing height or lesser trauma, or clinical osteoporosis
- •Metastatic prostate cancer
- •Inability to provide written informed consent
结局指标
主要结局
Our primary outcome variable will be change in spine bone mineral density over one year and change during the second year (or both years).
次要结局
- Secondary endpoints will be bone mineral density at the hip and lateral spine.
研究者
Susan L. Greenspan
Principal Investigator
University of Pittsburgh