Yonsei Med J.  2016 Jul;57(4):923-927. 10.3349/ymj.2016.57.4.923.

Vitamin D Repletion in Korean Postmenopausal Women with Osteoporosis

Affiliations
  • 1Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
  • 2Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
  • 3Department of Endocrinology and Metabolism, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
  • 4Department of Endocrinology and Metabolism, Pusan National University Hospital, Busan, Korea.
  • 5Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 6Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 7Department of Family Medicine, Cheil General Hospital, College of Medicine, Kwandong University, Seoul, Korea.
  • 8Department of Orthopedic Surgery, Kyungpook National University Hospital, Daegu, Korea.
  • 9GlaxoSmithKline, Seoul, Korea, Korea.
  • 10GlaxoSmithKline, Collegeville, PA, USA. barbara.g.kravitz@gsk.com

Abstract

PURPOSE
Up to 71% of South Korean postmenopausal women have vitamin D deficiency {serum 25-hydroxyvitamin D [25(OH) D] level <50 nmol/L}. Data on vitamin D supplementation was collected during the screening phase of an efficacy/safety study of denosumab in Korean postmenopausal women with osteoporosis. This report describes the effect of vitamin D supplementation on repletion to 25(OH)D levels ≥50 nmol/L in Korean postmenopausal women with osteoporosis.
MATERIALS AND METHODS
Vitamin D levels of Korean postmenopausal women (60-90 years old) were measured by extracting 25(OH)D2 and 25(OH)D3 from serum samples via protein precipitation and using liquid chromatography with tandem mass spectrometry detection. Calibration curves were constructed from the mass chromatograms to obtain total vitamin D levels. Subjects with serum 25(OH)D levels <50 nmol/L were supplemented with 1000 IU of vitamin D tablets during the 2.5-month-long screening period. Dose, frequency, and duration were determined by the investigator. If repletion was achieved (≥50 nmol/L) on retest, subjects were eligible to be rescreened for study entry.
RESULTS
Of 371 subjects screened, 191 (52%) required vitamin D supplementation, and 88% (168 of 191) were successfully repleted. More than half of the subjects (58%) who were successfully repleted received doses of 2000 IU daily. The mean time to successful repletion was 31 days (standard deviation 8.4 days; range 11-48 days).
CONCLUSION
Supplementation with daily median doses of 2000 IU vitamin D successfully repleted 88% of Korean postmenopausal women with osteoporosis within 48 days to a serum vitamin D level of 50 nmol/L.

Keyword

Vitamin D; postmenopause; osteoporosis; Korean

MeSH Terms

Aged
Aged, 80 and over
*Asian Continental Ancestry Group
Bone Density Conservation Agents/*therapeutic use
*Dietary Supplements
Double-Blind Method
Female
Humans
Middle Aged
Osteoporosis, Postmenopausal/*complications/drug therapy/ethnology
Postmenopause/blood
Republic of Korea
Vitamin D/analogs & derivatives/blood/*therapeutic use
Vitamin D Deficiency/diagnosis/*drug therapy/ethnology
Bone Density Conservation Agents
Vitamin D

Figure

  • Fig. 1 Subject flow of vitamin D supplementation in Korean study. A total of 135 patients met eligibility criteria and were randomized. *Subjects may have had more than 1 reason for screen failure.

  • Fig. 2 Time to achieve successful vitamin D repletion in Korean study. Of the 191 patients who entered the trial, 168 were fully repleted, and in 23, repletion to the goal of ≥50 nmol/L was not achieved.


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