A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,742
- 主要终点
- The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months.
研究概览
简要总结
The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.
详细描述
Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.
Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.
- •Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.
排除标准
- •One (1) or more osteoporotic vertebral fractures (T4-L4).
- •Diseases that may affect bone metabolism.
- •Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
结局指标
主要结局
The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months.
时间窗: 24 months
次要结局
- Additional BMD evaluation including total hip, femoral neck and trochanter at months 6, 12, 18 and 24. Serum bone markers at months 3, 6, 9, 12, 18 and 24. Lipid panel at months 3, 6, 12, 18 and 24.(Up to 24 months)