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 KimSung Kil Lim

Research output: Contribution to journalArticle

5 Citations (Scopus)

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-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.

Original languageEnglish
Pages (from-to)715-724
Number of pages10
JournalYonsei medical journal
Volume55
Issue number3
DOIs
Publication statusPublished - 2014 May

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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