NCT01128257已完成不适用
Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,054
- 主要终点
- Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment
研究概览
简要总结
This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate [Bonviva/Boniva] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 55 years of age
- •Postmenopausal osteoporosis
- •Patients who are in the opinion of the physician eligible to participate in this study
排除标准
- 未提供
研究组 & 干预措施
2
干预措施: alendronate (Drug)
1
干预措施: ibandronate [Bonviva/Boniva] (Drug)
结局指标
主要结局
Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment
时间窗: 12 months
次要结局
- Pain intensity and reduction in use of analgesics(12 months)
- Quality of life and patients satisfaction(12 months)
- Degree of patient's mobility(12 months)
- Incidence of new osteoporotic fractures(12 months)
- Controllability and management of therapy by the physician(12 months)
- Patient baseline characteristics(12 months)
- User friendliness(12 months)
- Safety: AEs and SAEs(12 months)
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