Yonsei Med J.  2014 May;55(3):715-724. 10.3349/ymj.2014.55.3.715.

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

• Kim KJ
• Min YK
• Koh JM
• Chung YS
• Kim KM
• Byun DW
• Kim IJ
• Kim M
• Kim SS
• Min KW
• Han KO
• Park HM
• Shin CS
• Choi SH
• Park JS
• Chung DJ
• Mok JO
• Baek HS
• Moon SH
• Kim YS
• Lim SK
• VALUE study group

• KMID: 2068682
• DOI: http://doi.org/10.3349/ymj.2014.55.3.715

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.

Keyword

Alendronate; vitamin-D; vitamin-D insufficiency; osteoporosis; parathyroid hormone

MeSH Terms

Adult
Aged
Alendronate/adverse effects/*therapeutic use
Cholecalciferol/adverse effects/deficiency/*therapeutic use
Female
Humans
Middle Aged
Osteoporosis, Postmenopausal/*drug therapy
Vitamin D Deficiency/*drug therapy
Alendronate
Cholecalciferol

Figure

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  Fig. 1 Summary of patient disposition.

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  Fig. 2 Mean change of 25-hydroxyvitamin D according to baseline 25-hydroxyvitamin D status. (A) Mean change of 25-hydroxyvitamin D in patients receiving alendronate containing 5600 IU of vitamin D3. (B) Mean change of 25-hydroxyvitamin D in patients receiving alendronate. ALN, alendronate.

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  Fig. 3 Percent change from baseline in serum PTH at 16 weeks. *p<0.01 between treatments. PTH, parathyroid hormone; ALN, alendronate.

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  Fig. 4 Neuromuscular Function Tests at 16 Weeks. *Fisher's exact test, **Chi-square test. ALN, alendronate.

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