Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
研究概览
简要总结
To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.
详细描述
To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In generally good health, as determined by medical history, physical examination, and laboratory test results
- •Postmenopausal greater than 2 years, naturally or surgically based on medical history.
排除标准
- •Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:
- •oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
- •anabolic steroids
- •estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
- •progestins
- •calcitonin
- •vitamin D supplements
- •calcitriol, calcidiol, or alfacalcidol at any dose
- •any bisphosphonate
- •strontium
- •parathyroid hormone, including teriparatide
研究组 & 干预措施
35 mg IRBB
35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
干预措施: risedronate (Drug)
35 mg DRFB
35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
干预措施: risedronate (Drug)
50 mg DRFB
50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
干预措施: risedronate (Drug)
50 mg DRBB
50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
干预措施: risedronate (Drug)
结局指标
主要结局
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
时间窗: Baseline and Week 13
次要结局
- Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population(Baseline and Week 13)
- Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population(Baseline and Week 13)