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RISS 인기검색어
- 검색키워드
- 저자 : Barbara Kravitz (검색결과 2 건)
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Vitamin D Repletion in Korean Postmenopausal Women with Osteoporosis
Barbara Kravitz,정윤석,정동진,강무일,김인주,고정민,민용기,오한진,박일형,이일섭,Brian Waterhouse,Lorraine A. Fitzpatrick,Antonio Nino 연세대학교의과대학 2016 Yonsei medical journal Vol.57 No.4
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. Subjectswith 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 postmenopausalwomen with osteoporosis within 48 days to a serum vitamin D level of 50 nmol/L.
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고정민,정동진,정윤석,강무일,김인주,민용기,오한진,박일형,이일섭,Brian Waterhouse,Antonio Nino,Lorraine A. Fitzpatrick,Barbara Kravitz 연세대학교의과대학 2016 Yonsei medical journal Vol.57 No.4
Purpose: The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosisin this phase III study. Materials and Methods: Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomizedto a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg. Results: Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbarspine bone mineral density (BMD) at Month 6 [3.2% (95% confidence interval 2.1%, 4.4%; p<0.0001)]}; and secondary endpoints(mean percent change from baseline in lumbar spine BMD at Month 1, total hip, femoral neck, and trochanter BMD at Months 1 and 6, and median percent change from baseline in bone turnover markers at Months 1, 3, and 6). Endpoint improvementswere sustained over 12 months in the open-label extension (n=119). There were no new or unexpected safety signals. Conclusion: Denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a 12-month period in Korean postmenopausal women. The findings of this study demonstrate that denosumab has beneficial effectson the measures of osteoporosis in Korean postmenopausal women.
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