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, seonghwan moon, Yong Soo Kim & 1 others Sungkil Lim

Research output: Contribution to journalArticle

4 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 Jan 1

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Alendronate
Cholecalciferol
Vitamin D
Safety
Serum
Least-Squares Analysis
Parathyroid Hormone
Osteoporosis
Odds Ratio
Regression Analysis
Confidence Intervals
Bone and Bones

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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, seonghwan ; Kim, Yong Soo ; Lim, Sungkil. / Efficacy and safety of weekly alendronate plus vitamin D3 5600 IU versus weekly alendronate alone in Korean osteoporotic women : 16-week randomized trial. In: Yonsei medical journal. 2014 ; Vol. 55, No. 3. pp. 715-724.
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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.",
author = "Kim, {Kwang Joon} and Min, {Yong Ki} and Koh, {Jung Min} and Chung, {Yoon Sok} and Kim, {Kyoung Min} and Byun, {Dong Won} and Kim, {In Joo} and Mikyung Kim and Kim, {Sung Soo} and Min, {Kyung Wan} and Han, {Ki Ok} and Park, {Hyoung Moo} and Shin, {Chan Soo} and Choi, {Sung Hee} and Park, {Jong Suk} and Chung, {Dong Jin} and Mok, {Ji Oh} and Baek, {Hong Sun} and seonghwan moon and Kim, {Yong Soo} and Sungkil Lim",
year = "2014",
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doi = "10.3349/ymj.2014.55.3.715",
language = "English",
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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, S, Kim, YS & Lim, S 2014, 'Efficacy and safety of weekly alendronate plus vitamin D3 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial', Yonsei medical journal, vol. 55, no. 3, pp. 715-724. https://doi.org/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, 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, seonghwan; Kim, Yong Soo; Lim, Sungkil.

In: Yonsei medical journal, Vol. 55, No. 3, 01.01.2014, p. 715-724.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of weekly alendronate plus vitamin D3 5600 IU versus weekly alendronate alone in Korean osteoporotic women

T2 - 16-week randomized trial

AU - Kim, Kwang Joon

AU - Min, Yong Ki

AU - Koh, Jung Min

AU - Chung, Yoon Sok

AU - Kim, Kyoung Min

AU - Byun, Dong Won

AU - Kim, In Joo

AU - Kim, Mikyung

AU - Kim, Sung Soo

AU - Min, Kyung Wan

AU - Han, Ki Ok

AU - Park, Hyoung Moo

AU - Shin, Chan Soo

AU - Choi, Sung Hee

AU - Park, Jong Suk

AU - Chung, Dong Jin

AU - Mok, Ji Oh

AU - Baek, Hong Sun

AU - moon, seonghwan

AU - Kim, Yong Soo

AU - Lim, Sungkil

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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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