NCT00549965已完成4 期
A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Phase IV Study in Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Actonel(Rosedronate) is Administered 35mg Once a Week or 5mg
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
- 202
- 试验地点
- 2
- 主要终点
- Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate.
研究概览
简要总结
Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Five (5) years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
- •Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (> than or = to 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Risedronate.
- •Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication they may be given at the discretion of the Investigator.
排除标准
- •Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.
- •Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
- •History of alcohol and/or drug abuse.
- •Subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication.
- •Subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the trial.
- •Excluded medications: bisphosphonates, calcitonin or fluoride or hormone replacement therapy within the last 6 months.
- •Known hypersensitivity to bisphosphonates and/or excipients.
- •Abnormal laboratory parameters, which are clinically relevant according to the Investigator (including renal insufficiency; creatinine clearance < 30 mL/min)
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Measurement of subject satisfaction of once a week 35 mg Risedronate and once daily 5 mg Risedronate.
时间窗: A subject-administered questionnaire at 12 and 24 weeks will assess satisfaction.
次要结局
- The subjects' compliance and persistence on treatment. Compliance as defined by more than 50% of the drug taken (by tablet count) during each Risedronate treatment period.(Persistence at week 12 and 24 will be defined as continuing Risedronate treatment.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Risedronate in the Prevention of Osteoporosis in Postmenopausal WomenOsteoporosis, PostmenopausalNCT00402441Sanofi260
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
2 期
Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot StudyAnkylosing SpondylitisNCT01038011University of Zurich
已完成
3 期
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With OsteoporosisOther OsteoporosisNCT00619957Warner Chilcott285