Chung Yoon Sok, Chung Dong Jin, Kang Moo Il, Kim In Ju, Koh Jung Min, Min Yong Ki, Oh Han Jin, Park Il Hyung, Lee Yil Seob, Kravitz Barbara, Waterhouse Brian, Fitzpatrick Lorraine A, Nino Antonio
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Yonsei Med J. 2016 Jul;57(4):923-7. doi: 10.3349/ymj.2016.57.4.923.
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.
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.
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).
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.
高达71%的韩国绝经后女性存在维生素D缺乏(血清25-羟基维生素D [25(OH)D]水平<50 nmol/L)。在一项针对韩国绝经后骨质疏松症女性的地诺单抗疗效/安全性研究的筛查阶段收集了维生素D补充的数据。本报告描述了维生素D补充对韩国绝经后骨质疏松症女性补充至25(OH)D水平≥50 nmol/L的影响。
通过蛋白质沉淀从血清样本中提取25(OH)D₂和25(OH)D₃,并使用液相色谱串联质谱检测法测量韩国绝经后女性(60 - 90岁)的维生素D水平。根据质量色谱图构建校准曲线以获得总维生素D水平。血清25(OH)D水平<50 nmol/L的受试者在为期2.5个月的筛查期内补充1000 IU维生素D片。剂量、频率和持续时间由研究者确定。如果复测时达到补充目标(≥50 nmol/L),受试者有资格重新筛查以进入研究。
在371名筛查的受试者中,191名(52%)需要补充维生素D,其中88%(191名中的168名)成功实现了补充。成功实现补充的受试者中超过一半(58%)每天接受2000 IU的剂量。成功补充的平均时间为31天(标准差8.4天;范围11 - 48天)。
每日补充中位数剂量2000 IU的维生素D能在48天内成功使88%的韩国绝经后骨质疏松症女性的血清维生素D水平达到50 nmol/L。