BONA (Adherence of Patients to Bonefos Therapy). Prospective Observational Non-interventional Study of Adherence of Patients to Bonefos Medication in Relation to Analgesic Effect and Incidence of Skeletal Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 147
- 主要终点
- Adherence to treatment with oral clodronate (PDC, proportion of days covered).
研究概览
简要总结
Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors
- •Bone metastases
- •Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos.
- •By agreeing to usage of patients diaries and goodwill with accounting of tablets
排除标准
- •According to SmPC (Summary of Product Characteristics) Bonefos.
研究组 & 干预措施
Group 1
干预措施: Clodronate (Bonefos, BAY94-8393) (Drug)
结局指标
主要结局
Adherence to treatment with oral clodronate (PDC, proportion of days covered).
时间窗: 12 months of therapy.
次要结局
- Efficacy evaluation of the therapy based on incidence of skeletal events(12 months)
- Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire(12 months)