NCT00402441已完成4 期
A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 35-mg Risedronate Administered Once a Week in the Prevention of Osteoporosis in Postmenopausal Women
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
研究概览
简要总结
Primary Objective:
- To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.
Secondary objectives:
- To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal
- To assess the general safety of 35-mg risedronate administered once weekly.
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 (Participant, Investigator)
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
- •The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- •Main Inclusion/
排除标准
- •are listed hereafter:
- •Inclusion criteria:
- •Be postmenopausal for 0.5-5 years.Menopause is defined as 12 months without menses, based on medical history. Subjects who are post-menopausal secondary to bilateral oophorectomy must have serum FSH >40 mIU/mL and estradiol <20 pg/mL.
- •Subjects with 3 contiguous lumbar spine vertebral bodies (L1-L4) without fracture or degenerative disease.
- •Lumbar spine BMD mean value > 0.772g/cm2 (Hologic) or >0.880 g/cm2 (Lunar).
- •Exclusion criteria :
- •Subjects with adequate lumbar spine BMD but osteoporotic by total proximal femur BMD (<0.637 g/cm2 [Hologic]) or <0.694 g/cm2 [Lunar]) as determined by dual-energy x-ray absorptiometry (DXA)
结局指标
主要结局
Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
次要结局
- Percent change from baseline to Months 6 and 12 in lumbar spine BMD
- and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
- Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal WomenOsteoporosis, PostmenopausalNCT00353080Sanofi171
已完成
3 期
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal WomenOsteoporosis PostmenopausalNCT00358176Sanofi1,231
已完成
3 期
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With OsteoporosisOther OsteoporosisNCT00619957Warner Chilcott285
已完成
2 期
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMDPostmenopausalNCT00577837Warner Chilcott370
已完成
4 期
Satisfaction and Compliance of Risedronate in PMOOsteoporosis, PostmenopausalNCT00549965Sanofi202