Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles
研究概览
简要总结
A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal
排除标准
- •use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:
- •oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day)
- •anabolic steroids
- •estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring
- •progestogen
- •calcitonin
- •vitamin D supplements (greater than 800 IU per day)
- •calcitriol, calcidiol, or alfacalcidol
- •any bisphosphonate
- •fluoride (10 mg per day)
- •strontium and other bone active agents
- •parathyroid hormone
- •heparin, warfarin, and other similar anticoagulants
研究组 & 干预措施
1
5 mg risedronate, once daily for 6 months
干预措施: risedronate (Drug)
2
100 mg risedronate, once a month for 6 months
干预措施: risedronate (Drug)
3
150 mg risedronate, once a month for 6 months
干预措施: risedronate (Drug)
4
200 mg risedronate, once a month for 6 months
干预措施: experimental (Drug)
结局指标
主要结局
Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles
时间窗: 6 months
次要结局
- Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens(6 months)