Efficacy and safety of weekly alendronate plus vitamin D₃ 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-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.
Division of Endocrinology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. ; Severance Executive Healthcare Clinic, Severance Hospital, Yonsei University Health System, Seoul, Korea. ; Severance Check-up, Severance Hospital, Yonsei University Health System, Seoul, Korea.
Kwang Joon
KJ
Kim
Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Yong-Ki
YK
Min
Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Jung-Min
JM
Koh
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
Yoon-Sok
YS
Chung
Division of Endocrinology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Kyoung Min
KM
Kim
Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.
Dong-Won
DW
Byun
Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
In Joo
IJ
Kim
Division of Endocrinology, Department of Internal Medicine, Maryknoll Medical Center, Busan, Korea.
Mikyung
M
Kim
Division of Rheumatology, Department of Internal Medicine, University of Ulsan College of Medicine, Gangneung Asan Hospital, Gangneung, Korea.
Sung-Soo
SS
Kim
Department of Endocrinology and Metabolism, Eulji University College of Medicine, Seoul, Korea.
Kyung Wan
KW
Min
Division of Endocrinology, Department of Internal Medicine, Cheil General Hospital and Woman's Health Center, Kwandong University School of Medicine, Seoul, Korea.
Ki Ok
KO
Han
Department of Obstetrics and Gynecology, Chung-Ang University College of Medicine, Seoul, Korea.
Hyoung Moo
HM
Park
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Chan Soo
CS
Shin
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Sung Hee
SH
Choi
Division of Endocrinology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Jong Suk
JS
Park
Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Dong Jin
DJ
Chung
Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
Ji Oh
JO
Mok
Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
Hong Sun
HS
Baek
Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Seong-Hwan
SH
Moon
MSD Korea Ltd., Global Medical Affairs, Seoul, Korea.
Yong Soo
YS
Kim
Division of Endocrinology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Sung-Kil
SK
Lim
D000328:Adult; D000368:Aged; D019386:Alendronate / Q000009:adverse effects / Q000627:therapeutic use*; D002762:Cholecalciferol / Q000009:adverse effects / Q000172:deficiency / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D014808:Vitamin D Deficiency / Q000188:drug therapy*
D002762:Cholecalciferol; D019386:Alendronate
Alendronate; osteoporosis; parathyroid hormone; vitamin-D; vitamin-D insufficiency