NCT00351091已完成2 期
a Six Month, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study to Estimate the Pharmacodynamic Response of Two Risedronate Regimens Compared With 5mg Daily : 150mg Monthly Dose for Six Months and 15mg Daily for Thirty Days Followed by 150mg Monthly Dose for 5 Months in Postmenopausal Women With Low Bone Density.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 150
- 主要终点
- Urine NTX at week 4 of month 6
研究概览
简要总结
The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months
The secondary objectives are :
- To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
- To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate.
- To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
- To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ambulatory women,postmenopausal >= 5 years
- •have lumbar spine baseline BMD within the following criterion :
- •Hologic: <= 0.827 g/cm2 or
- •Lunar: <= 0.942 g/cm2 or
- •Norland: <= 0.768 g/cm2
- •be in general good health as determined by medical history, physical examination and laboratory tests
排除标准
- •serum 25-OH vitamin D level <= 12 ng/ml
- •history of osteomalacia
- •history of active hyperparathyroidism or hyperthyroidism
- •hypocalcemia or hypercalcemia from any cause
- •depot injection >10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
- •use of Vitamin D supplementation within 3 months prior to starting the investigational product
- •use of any of the following medications within a specified number of months prior to starting the investigational product :
- •any bisphosphonate.
- •use of any fluoride with the exception of fluoride use for oral hygiene
- •strontium
- •other bone active agents
- •subcutaneous estrogen implant
- •oral or parenteral glucocorticoids
- •anabolic steroids
- •estrogen or estrogen-related drugs, except for low dose vaginal creams
- •progestogen
- •calcitonin, calcitriol, or calcifediol
- •any allergic or abnormal reaction to bisphosphonates
- •creatinine clearance < 30 ml/min
结局指标
主要结局
Urine NTX at week 4 of month 6
次要结局
- Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD
研究者
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