An Observational Study Assessing Effects on Quality of Life, Medication Compliance, Treatment Satisfaction in Patients With Combination Therapy With Raloxifene/Cholecalciferol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,907
- 试验地点
- 1
- 主要终点
- The EuroQol EQ-5D
研究概览
简要总结
This study examines quality of life and patient satisfaction in postmenopausal women receiving raloxifene to prevent/treat osteoporosis, and vitamin D to reduce risk of fracture using clinical practice data. The purpose of this study is to observe quality of life(QOL), medication compliance and patient satisfaction who got combination therapy with raloxifene/cholecalciferol (raloxifene 60mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) for 6 months.
详细描述
Preventing bone loss is an important concern for women during post-menopausal period. Menopause significantly speeds bone loss and increases the risk for osteoporosis. This study was to investigate the effectiveness on quality of life (QOL), patient satisfaction in postmenopausal women receiving raloxifene/cholecalciferol combination therapy. In addition, we analyzed adverse events to assess the safety profile of this drug.
This study is a multicenter, prospective, non-critical observational study of women receiving raloxifene/cholecalciferol (raloxifene 60mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) combination therapy to treat or prevent postmenopausal osteoporosis. Data will be collected from patients receiving routine treatment at about 105 primary, secondary, or tertiary medical institutions in South Korea. Each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine changes in, and factors influencing quality of life (EQ-5D-5L method), patient satisfaction with efficacy and convenience (questionnaire), and safety. This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women who need to prevent/treat osteoporosis
- •Subject who got raloxifene/cholecalciferol combination therapy prescription with confirmation by the investigator's medical decision
- •Subjects who can consent voluntarily
排除标准
- •Patients for whom use of raloxifene/cholecalciferol combination therapy is prohibited
- •Pregnant women, nursing women or child-bearing aged females deemed capable of pregnancy
结局指标
主要结局
The EuroQol EQ-5D
时间窗: 6 months
Change and impact factor of quality of life measured with the EuroQol (EQ-5D) EQ-5D-5L is designed to measure health conditions and it consists of 5 questions relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Measuring EQ-5D is performed at each visit. The EQ-5D-5L consists of descriptive system with 5 dimensions. Each dimension has 5 levels: No problems(1), Slight problems(2), Moderate problems(3), Severe problems(4), and Extreme problems(5).
次要结局
- Occurrence and aspect of adverse events(AEs)(6 months)
- Medication compliance (Rate of subjects taking more than 80% of the medication)(6 months)
- Evaluation of clinical laboratory changes (BTM(Bone turnover marker) P1NP)(6 months)
- Reason for medication change(6 months)
- Evaluation of clinical laboratory changes (BTM(Bone turnover marker) CTX)(6 months)
- Evaluation of clinical laboratory changes (BTM(Bone turnover marker) BAP)(6 months)
- Evaluation of clinical laboratory changes (BTM(Bone turnover marker) osteocalcin)(6 months)
- Treatment satisfaction measured with questionnaire (Patient satisfaction)(6 months)
- Evaluation of clinical laboratory changes (BTM(Bone turnover marker) NTX)(6 months)
- Evaluation of clinical laboratory changes (25(OH)D level(25-hydroxyvitamin D level)(6 months)
- Evaluation of quality of life changes compared with prior medication regimens(6 months)