| Summary: | Ho Yeon Chung,1 Jawon Koo,1 Su Kyoung Kwon,2 Moo-IL Kang,3 Seong-Hwan Moon,4 Jin-Young Park,5 Chan Soo Shin,6 Byung-Koo Yoon,7 Hyun-Koo Yoon,8 Jae-Suk Chang,9 Yoon-Sok Chung,10 Hyoung-Moo Park111Department of Internal Medicine, Kyung Hee University, 2Department of Statistics, 3Department of Internal Medicine, Catholic University of Korea, 4Department of Orthopedics, Yonsei University, 5Department of Orthopedics, Konkuk University, 6Department of Internal Medicine, Seoul National University, 7Department of Obstetrics and Gynecology, Sungkyunkwan University, 8Department of Internal Medicine, Kwandong University, 9Department of Orthopedics, University of Ulsan, Seoul, South Korea; 10Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea; 11Department of Obstetrics and Gynecology, Chung-Ang University, Seoul, South KoreaPurpose: This study investigated the efficacy and safety of monthly risedronate, with and without cholecalciferol, on 25-hydroxyvitamin D (25[OH]D) levels and bone markers in Korean patients with osteoporosis.Methods: A randomized, double-blinded, prospective, 16-week clinical trial was conducted in ten hospitals. A total of 150 subjects with osteoporosis were randomized to one of the two treatment groups: RSDM+ (monthly risedronate 150 mg and cholecalciferol 30,000 IU combined in a single pill, n = 74) or RSDM (monthly risedronate 150 mg alone, n = 76). We measured serum levels of 25-hydroxyvitamin D (25[OH]D), parathyroid hormone (PTH), and bone markers, as well as performing muscle-function tests at baseline and after 16 weeks of treatment.Results: After 16 weeks, serum 25(OH)D levels significantly increased from 17.8 to 26.8 ng/mL in the RSDM+ group, but did not change in the RSDM group. The RSDM+ group exhibited significantly decreased serum PTH from 46 to 36.7 pg/mL, while the RSDM group showed a tendency for PTH to increase from 38 to 40.6 pg/mL. In both groups, serum bone-specific alkaline phosphatase and C-terminal telopeptide rapidly declined, with significance at 16 weeks; there were no significant differences between the groups.Conclusion: A once-monthly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D levels over the 16-week treatment period without significant adverse events in Korean patients with osteoporosis. Keywords: bisphosphonate, cholecalciferol, bone markers, 25(OH)D
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