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Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial
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 v...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Yonsei University College of Medicine
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3990072/ https://www.ncbi.nlm.nih.gov/pubmed/24719139 http://dx.doi.org/10.3349/ymj.2014.55.3.715 |
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author | 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 |
author_facet | 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 |
author_sort | Kim, Kwang Joon |
collection | PubMed |
description | 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 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. |
format | Online Article Text |
id | pubmed-3990072 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Yonsei University College of Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-39900722014-05-01 Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 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, Seong-Hwan Kim, Yong Soo Lim, Sung-Kil Yonsei Med J Original Article 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 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. Yonsei University College of Medicine 2014-05-01 2014-04-01 /pmc/articles/PMC3990072/ /pubmed/24719139 http://dx.doi.org/10.3349/ymj.2014.55.3.715 Text en © Copyright: Yonsei University College of Medicine 2014 http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article 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 Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial |
title | Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial |
title_full | Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial |
title_fullStr | Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial |
title_full_unstemmed | Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial |
title_short | Efficacy and Safety of Weekly Alendronate Plus Vitamin D(3) 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial |
title_sort | efficacy and safety of weekly alendronate plus vitamin d(3) 5600 iu versus weekly alendronate alone in korean osteoporotic women: 16-week randomized trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3990072/ https://www.ncbi.nlm.nih.gov/pubmed/24719139 http://dx.doi.org/10.3349/ymj.2014.55.3.715 |
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