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

Hanmi Pharmaceutical

Status: Completed

Conditions: Osteoporosis

Treatments: Other: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT04788290

HM-RAB-OS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,907 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients for whom use of raloxifene/cholecalciferol combination therapy is prohibited
• Pregnant women, nursing women or child-bearing aged females deemed capable of pregnancy

Trial design

3,907 participants in 1 patient group

Single group(No interventional)

Description:

Other Name: Observational Rabone D®, Once daily administered per the locally approved product information

Treatment:

Other: Observational