NCT00549068已完成4 期
Impact of NTx Point of Care (POC) Device on Patient Satisfication With Actonel 35mg Once a Seek Treatment a Multicenter Prospective Open Label Randomized Controlled Community Practice-based Study
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
- 2,433
- 主要终点
- Compare subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel® 35 mg Once-a-Week for 24 weeks, and receiving feedback information after 12 weeks of treatment to similar women monitored as per regular clinical practice
研究概览
简要总结
To compare the subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel 35mg Once-a-Week for 24 weeks, and receiving feedback information, after 12 weeks of treatment, based on bone resorption marker results using the NTx Point-Of-Care (POC) device, to similar women treated as per regular clinical practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with postmenopausal osteoporosis using community practice standards
- •Women previously non-treated for osteoporosis, OR treated for osteoporosis with biphosphonates (alendronate, etidronate), hormone replacement therapy estrogen, estrogen-related drugs, progesterone, subcutaneous estrogen implant), raloxifene, fluoride, or calcitonin within the past 2 years but discontinued prior to enrolment into the study either due to:lack of effect or intolerance
排除标准
- •Subjects treated with Actonelr 5 mg daily,
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- •Known/Suspected hypersensitivity to any component of Actonelr 35 mg Once-a-Week
- •Known/Suspected hypocalcaemia
- •Known/Suspected severe renal impairment (creatinine clearance < 30ml/min)
- •Known/Suspected hyperparathyroidism
- •Known/Suspected hyperthyroidism
- •Known/Suspected active urinary tract infection
- •Known high urine levels of calcium (3 4mg/ml)
- •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
Compare subject satisfaction rating in women treated for postmenopausal osteoporosis with Actonel® 35 mg Once-a-Week for 24 weeks, and receiving feedback information after 12 weeks of treatment to similar women monitored as per regular clinical practice
次要结局
- Compare subject satisfaction with Actonel® 35 mg Once-a-Week in subject subgroups: previously treated with biphosphonates, HRT, raloxifene, fluoride, or calcitonin within past 2 years vs. those previously non treated
研究者
相似试验
已完成
不适用
Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoopArthroplasty, Replacement, KneeArthroplasty, Replacement, HipNCT03481595The Cleveland Clinic294
Unknown
4 期
Osteoporosis Treatment in Post-menopausal WomenDepressive SyndromeNCT03006003Taichung Veterans General Hospital500
已完成
不适用
Inpatient vs Outpatient Total Knee ReplacementOsteoarthritis, KneeNCT04228731London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's123
已完成
不适用
Patient Satisfaction , Prosthetic Complications and Clinical Outcomes of PEEK Composite Versus Titanium ZirconiumPatient SatisfactionProsthetic ComplicationClinical OutcomesNCT06111391Mansoura University30
已完成
不适用
Quality of Life(QoL) in Korean Postmenopausal Osteoporosis Patients With Bisphosphonate TreatmentOsteoporosis, PostmenopausalNCT01227369GlaxoSmithKline4,376