The Efficacy and Safety of a Combined Alendronate and Calcitriol Agent (Maxmarvil): A Postmarketing Surveillance Study in Korean Postmenopausal Women with Osteoporosis
Hee-Won Suh, Hyun-Ok Kim, Young Sik Kim*, Sung Sunwoo, Jung Ah Lee, Hye-Ree Lee1, Byungsung Kim2, Dae Hyun Kim3, Youn Seon Choi4, Yoo Seock Cheong5, Keunsang Yum6, Yun Jun Yang7, Byung-Yeon Yu8, Chung Hwan Cho9, Sat-Byul Park10, Dong Hyeok Shin11, Korea Post-Marketing Surveillance Research Group12
Department of Family Medicine, Asan Medical Center, University of Ulsan College of Medicine; 1Department of Family Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine; 2Department of Family Medicine, Kyung Hee University Hospital, Kyung Hee University School of Medicine, Seoul; 3Department of Family Medicine, Dongsan Medical Center, Keimyung University School of Medicine, Daegu; 4Department of Family Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul; 5Department of Family Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan; 6Department of
Family Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea College of Medicine, Uijeongbu; 7Department of Family Medicine, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang; 8Department of Family Medicine, Konyang University Hospital, Konyang University College of Medicine, Daejeon; 9Department of Family Medicine, Presbyterian Medical Center, Jeonju; 10Department of Family Medicine, Ajou University Hospital, Ajou University School of Medicine, Suwon; 11Department of Family Medicine, Mizmedi Hospital; 12The Korean Academy of Family Medicine, Seoul, Korea
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Background: Combined therapy with alendronate and calcitriol may have additive effects on bone density. An observational study was performed to evaluate the efficacy and safety of Maxmarvil, a combinative agent of alendronate (5 mg) and calcitriol (0.5 Ռg), and to identify factors associated with efficacy.
Methods: A total of 568 postmenopausal women with osteoporosis were enrolled by family physicians in 12 hospitals. The study subjects took Maxmarvil daily for 12 months. Questionnaires about baseline characteristics, socioeconomic status, and daily calcium intake were completed at the first visit. Adverse events were recorded every 3 months and bone mineral density (BMD) in the lumbar spine was measured using dual-energy X-ray absorptiometry at baseline and after 12 months. We evaluated the efficacy and safety of Maxmarvil, and the factors related to BMD improvement.
Results: A total of 370 patients were included in final analysis. The median BMD was 0.81 ¡¾ 0.12 g/cm2 at pre-treatment and 0.84 ¡¾ 0.13 g/cm2 after one year. The average BMD improvement was 3.4% ¡¾ 6.4% (P < 0.05), and 167 (45.1%) patients showed improvement. Factors associated with improved BMD were continuation of treatment (odds ratio [OR], 2.41; 95% confidence interval [CI], 1.15 to 5.07) and good compliance (OR, 2.54; 95% CI, 1.29 to 5.00). Adverse events were reported by 35 of the 568 patients, with the most common being abdominal pain and dyspepsia.
Conclusion: Maxmarvil was found to be safe, well tolerated and effective in osteoporosis treatment. Continuation of treatment and good compliance were the factors associated with efficacy.