골감소증 및 골다공증을 동반한 폐경후 여성에서 경구 칼시페디올의 효과
The Effects of Oral Calcifediol in Postmenopausal Women with Osteopenia and Osteoporosis
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목적: 골감소증 및 골다공증을 가진 한국의 폐경후 여성들을 대상으로 경구 25(OH)D 제제를 투여한 후, 비타민 D 관련 골대사지표와 부작용을 평가하고자 하였다. 방법: 1개 대학병원 내분비대사내과 외래에서 모집된 60명의 여성을 대상으로 하였다. 대상자를 두 그룹으로 임의로 배정하여 실험군은 경구 칼시페디올(칼디올Ⓡ, 20μg; 메디카코리아)을, 대조군은 위약을 1일 1회 용법으로 8주간 복용한 후 혈중 25-hydroxyvitamin D와 부갑상선호르몬 수치, 부작용 여부를 추적 관찰하였다. 결과: 칼시페디올군에서는 8주 뒤 90.3%에서 혈중 25-hydroxyvitamin D 농도가 75 nmol/L 이상에 도달하였으며, 위약군과 비교하였을 때 유의한 차이를 나타냈다(102.1±32.0 vs. 31.5±12.0 nmol/L; P<0.0001). 실험군에서 8주 뒤 혈중 부갑상선호르몬 수치의 의미 있는 감소를 보였으나(P<0.01), 위약군과 비교하였을 때에는 통계적으로 유의한 차이를 보이지 않았다(21.1±7.7 vs. 25.6±12.7 pg/mL; P=0.234). 약제와 관련된 부작용은 없었다. 결론: 골감소증 또는 골다공증을 동반한 한국인 폐경후 여성에게 경구 칼시페디올을 매일 20ug, 8주간 투여하였을 때, 약제와 연관된 부작용 없이 혈중 25- hydroxyvitamin D 농도의 유의한 증가를 볼 수 있었다.
Abstract
Objectives: The purpose of this study was to evaluate the effects of oral 25(OH)D on vitamin D related bone metabolic factors and adverse events in Korean postmenopausal women with osteopenia and osteoporosis. Methods: A total 60 women from outpatient Department of Endocrinology and Metabolism were enrolled in this study. A phase IV clinical trial was conducted in which a randomized double-blind, placebo- controlled study with calcifediol (CaldiolⓇ, 20μg daily; Medica Korea Co., Ltd., South Korea) or placebo for 8 weeks. Serum 25-hydroxyvitamin D and parathyroid hormone levels were measured at 0, 4, and 8 weeks and adverse events were monitored. Results: In the calcifediol group, the serum 25-hydroxyvitamin D levels were>75 nmol/L in 90.3% of the subjects at 8 weeks, and significantly higher compared with the placebo group (102.1±32.0 vs. 31.5±12.0 nmol/L; P<0.0001). Although the serum PTH level was significantly decreased after 8 weeks in the calcifediol group (P<0.01), there was no significance when compared with the placebo group (21.1±7.7 vs. 25.6±12.7 pg/mL; P=0.234). There was no drug-related adverse event. Conclusion: Oral calcifediol improved serum 25-hydroxyvitamin D status without drug-related adverse events in Korean postmenopausal women with osteopenia and osteoporosis.
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