NCT00247273已完成3 期
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,294
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
研究概览
简要总结
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
详细描述
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female: 50 years of age or older
- •>5 years since last menses natural or surgical
- •have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
排除标准
- •history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- •BMI (body mass index) >32 kg/m^2
- •use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
- •hypocalcemia or hypercalcemia of any cause
- •markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
研究组 & 干预措施
1
Active Comparator
5 mg risedronate, once daily for 2 years
干预措施: risedronate (Drug)
2
Experimental
150 mg risedronate taken once a month for 2 years
干预措施: risedronate (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
时间窗: Baseline to Month 12 - Endpoint
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
次要结局
- Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population(Baseline to Month 24)
- Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population(Baseline to Month 6)
- Change From Baseline in Urine NTX/Cr at Month 24, ITT Population(Baseline to Month 24)
- Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)(Baseline to Month 24 - Endpoint)
- Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population(Baseline to Month 24)
- Percent Change From Baseline in Serum CTX at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Serum BAP at Month 24, ITT Population(Baseline to Month 24)
- Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population(Baseline to Month 12)
- Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population(Baseline to Month 12)
- Change From Baseline in Serum CTX at Month 24, ITT Population(Baseline to Month 24)
- Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population(Baseline to Month 6)
- Change From Baseline in Serum BAP at Month 24, ITT Population(Baseline to Month 24)
- Number of Participants With New Vertebral Fracture at Month 12, ITT Population(Baseline to Month 12)
- Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population(Baseline to Month 24)
- Percent Change From Baseline in Serum BAP at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Serum CTX at Month 24, ITT Population(Baseline to Month 24)
- Number of Participants With New Vertebral Fracture at Month 24, ITT Population(Baseline to Month 24)
研究者
研究点 (1)
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