NCT01552122撤回3 期
A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck
研究概览
简要总结
This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In good general health, and postmenopausal for at least 5 years or more
- •Diagnosed with postmenopausal osteoporosis
- •Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
- •One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
- •Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study
排除标准
- •Evidence of metabolic bone disorder
- •History of malignancy (cancer) for 5 years or less
- •Active thyroid disease that cannot be managed with medication
- •Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
- •Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history
- •(within the last year) of drug or alcohol abuse or dependence
- •Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®)
- •Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)
研究组 & 干预措施
Odanacatib
Experimental
干预措施: Placebo (alendronate) (Other)
Odanacatib
Experimental
干预措施: Odanacatib (Drug)
Odanacatib
Experimental
干预措施: Cholecalciferol (Vitamin D3) (Dietary Supplement)
Odanacatib
Experimental
干预措施: Calcium carbonate (Dietary Supplement)
Alendronate
Active Comparator
干预措施: Alendronate (Drug)
Alendronate
Active Comparator
干预措施: Placebo (odanacatib) (Other)
Alendronate
Active Comparator
干预措施: Cholecalciferol (Vitamin D3) (Dietary Supplement)
Alendronate
Active Comparator
干预措施: Calcium carbonate (Dietary Supplement)
结局指标
主要结局
Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck
时间窗: Baseline and Month 24
次要结局
- Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter(Baseline and Month 24)
研究者
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