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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3907 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-06

Study Completion Date

2020-07-13

Brief Summary

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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.

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Detailed Description

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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

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Osteoporosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Single group(No interventional)

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

Observational

Intervention Type OTHER

Rabone D®, Once daily administered per the locally approved product information

Interventions

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Observational

Rabone D®, Once daily administered per the locally approved product information

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No