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Efficacy and Safety of Weekly Alendronate Plus Vitamin D₃ 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial

 Kwang Joon Kim  ;  Yong-Ki Min  ;  Jung-Min Koh  ;  Yoon-Sok Chung  ;  Kyoung Min Kim  ;  Dong-Won Byun  ;  In Joo Kim  ;  Mikyung Kim  ;  Sung-Soo Kim  ;  Kyung Wan Min  ;  Ki Ok Han  ;  Hyoung Moo Park  ;  Chan Soo Shin  ;  Sung Hee Choi  ;  Jong Suk Park  ;  Dong Jin Chung  ;  Ji Oh Mok  ;  Hong Sun Baek  ;  Seong-Hwan Moon  ;  Yong Soo Kim  ;  Sung-Kil Lim 
 YONSEI MEDICAL JOURNAL, Vol.55(3) : 715-724, 2014 
Journal Title
Issue Date
Adult ; Aged ; Alendronate/adverse effects ; Alendronate/therapeutic use* ; Cholecalciferol/adverse effects ; Cholecalciferol/deficiency ; Cholecalciferol/therapeutic use* ; Female ; Humans ; Middle Aged ; Osteoporosis, Postmenopausal/drug therapy* ; Vitamin D Deficiency/drug therapy*
Alendronate ; osteoporosis ; parathyroid hormone ; vitamin-D ; vitamin-D insufficiency
Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D₃ (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Kwang Joon(김광준) ORCID logo https://orcid.org/0000-0002-5554-8255
Moon, Seong Hwan(문성환)
Lim, Sung Kil(임승길)
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