NCT04788290

An Observational Study Assessing Effects in Patients With Combination Therapy With Raloxifene/Cholecalciferol

An Observational Study Assessing Effects on Quality of Life, Medication Compliance, Treatment Satisfaction in Patients With Combination Therapy With Raloxifene/Cholecalciferol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,907 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
OTHER	Observational	Rabone D®, Once daily administered per the locally approved product information

Timeline

• Start date: 2017-11-06
• Primary completion: 2020-07-13
• Completion: 2020-07-13
• First posted: 2021-03-09
• Last updated: 2021-03-09

Locations

1 site across 1 country: South Korea