Efficacy and Safety of Weekly Alendronate Plus Vitamin D-3 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial
- Authors
- Kim, Kwang Joon; Min, Yong-Ki; Koh, Jung-Min; Chung, Yoon-Sok; Kim, Kyoung Min; Byun, Dong-Won; Kim, In Joo; Kim, Mikyung; Kim, Sung-Soo; Min, Kyung Wan; Han, Ki Ok; Park, Hyoung Moo; Shin, Chan Soo; Choi, Sung Hee; Park, Jong Suk; Chung, Dong Jin; Mok, Ji Oh; Baek, Hong Sun; Moon, Seong-Hwan; Kim, Yong Soo; Lim, Sung-Kil
- Issue Date
- 1-May-2014
- Publisher
- 연세대학교의과대학
- Keywords
- Alendronate; vitamin-D; vitamin-D insufficiency; osteoporosis; parathyroid hormone
- Citation
- Yonsei Medical Journal, v.55, no.3, pp 715 - 724
- Pages
- 10
- Journal Title
- Yonsei Medical Journal
- Volume
- 55
- Number
- 3
- Start Page
- 715
- End Page
- 724
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/12202
- DOI
- 10.3349/ymj.2014.55.3.715
- ISSN
- 0513-5796
1976-2437
- Abstract
- 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-D-3 (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 end-point] 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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