NCT00310531已完成3 期
A Multicenter, Double-Blind, Double-Dummy, Randomized, Active- Controlled, 3-Year Study to Evaluate the Antiresorptive Efficacy, Safety and Tolerability of a Ultra-Low Dose Estradiol Transdermal Delivery System Releasing 0.014 mg / Day Versus Oral Raloxifene Hydrochloride 60 mg / Day - as a Therapy for the Prevention of Osteoporosis in Postmenopausal Female Osteopenic Patients.
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
- Bayer
- 入组人数
- 500
- 主要终点
- Percentage change in Bone Mineral Density at the lumbar spine
研究概览
简要总结
The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Last (regular) menstrual period more than 5 years ago
- •Relative good state of health
- •Intact, normal uterus
排除标准
- •Bone and musculoskeletal diseases
- •Clinically significant vertebral fracture within the last 12 months
- •Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
- •Uncontrolled diabetes mellitus (or treated with insulin)
- •Uncontrolled thyroid disorders
- •Relevant renal disorder or significant liver dysfunction (including cholestasis)
- •History of alcohol or drug abuse
- •History of immobilization of more than 2 months in the last 6 months
- •Smoking of more than 10 cigarettes per day
- •Unexplained uterine bleeding
- •Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Menostar (Estradiol, BAY86-5435) (Drug)
Arm 2
Active Comparator
干预措施: Raloxifene (Drug)
结局指标
主要结局
Percentage change in Bone Mineral Density at the lumbar spine
时间窗: after 3 years
次要结局
- Percentage change in biochemical markers of bone turnover(after 6 months)
- Proportion of patients with hot flushes(after 3 year)
- Percentage change in Bone Mineral Density of the hip(after 3 years)
- Proportion of patients with an abnormal endometrial biopsy(after 3 years)
- Digital breast density analysis(after 2 years)
- Change in Women's Health Questionnaire(after 2 years)
- Pharmacogenetic analysis(after 2 years)
研究者
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