An Observational Study to Assess the Safety and Efficacy on Quality of Life and Patient Satisfaction With Raloxifene/Cholecalciferol Combination Therapy in Postmenopausal Women Requiring Prevention or Treatment for Osteoporosis

Abstract

Background: Preventing bone loss is an important concern for women during post-menopausal period. Menopause significantly speeds bone loss and increases the risk for osteoporosis. The aim of 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. Methods: This study is a multicenter, prospective, non-interventional observational study of women receiving raloxifene/cholecalciferol (raloxifene 60 mg + cholecalciferol 800 IU, Rabone D®, Hanmi Pharma, South Korea) combination therapy to treat or prevent postmenopausal osteoporosis. Data have been collected from patients receiving routine clinical practice at 99 hospitals (local clinics and general hospitals) in South Korea. Patients were followed for more than 6 months to evaluate changes in, and QOL (EQ-5D-5L), patient satisfaction with efficacy and convenience (questionnaire), and safety. This study has been approved by Institutional Review Board and is in compliance with clinical research ethics regulations. Results: A total of 3,907 subjects with an average age of 67.68 ± 9.34 (Mean ± SD) were enrolled from November 2017 to July 2020. QOL was significantly improved from 0.77 ± 0.15 to 0.80 ± 0.12, 0.82 ± 0.11 (3 months, 6 months, respectively) after raloxifene/cholecalciferol therapy (p<0.001). Compared to prior drug regimens of all types (bisphosphonates, bisphosphonates with vitamin D, selective estrogen receptor modulators, etc.), QOL after raloxifene/cholecalciferol treatment was significantly improved (p<0.001). Patient satisfaction of efficacy was significantly increased from 37.25% to 67.70% over 6 months (p<0.0001), and patient satisfaction of convenience was significantly increased from 42.75% to 74.07% (p<0.0001). Serious adverse drug reaction (ADR) did not occur. Hot flush as ADR occurred in 12 subjects (0.30%), lower than Caucasian but similar with previous reports in Asians. Conclusion: In postmenopausal women, combination therapy with raloxifene/cholecalciferol significantly improved quality of life, and patient satisfaction with no serious adverse events. This drug regimen has been proven to be suitable therapy for postmenopausal women with osteoporosis in a real-world clinical setting.