Raloxifene/Vitamin D Combination Therapy vs. Raloxifene Monotherapy on Serum 25-Hydroxy- Vitamin D Level among Postmenopausal Women with Osteoporosis or Osteopenia: A Randomized Controlled Trial

다국어 초록 (Multilingual Abstract)

Background: We compared the efficacy of a fixed dose combination of raloxifene 60 mg/vitamin D 800 IU to raloxifene 60 mg alone on vitamin D status, as indicated by change in serum 25-hydroxy-vitamin D (25[OH]D) levels. Methods: In this 16-week, open-label, randomized, active controlled, multicenter clinical trial conducted in 4 uni- versity-affiliated hospitals in Korea, postmenopausal women aged 55 to 70 years with osteoporosis or osteopenia were randomly assigned in a 1:1 ratio to receive raloxifene 60 mg/cholecalciferol 800 IU combination therapy or raloxifene 60 mg monotherapy. Primary endpoint was change in serum 25(OH)D level from baseline to 16 weeks after the intervention. Results: A total of 96 participants were randomly assigned to raloxi- fene/vitamin D combination therapy (N= 49) and raloxifene monotherapy (N= 47) groups. At week 16, serum 25(OH)D level increased from baseline, only in the raloxifene/ vitamin D combination therapy group. Change in serum 25(OH)D level from baseline to week 16 was higher in the raloxifene/vitamin D combination therapy group (2.7±6.5 ng/mL) than in the raloxifene monotherapy (-1.7±6.2 ng/mL; P = 0.0034) group. Propor- tions and number of adverse events (AEs) categorized by the System-Organ Class were not different between the groups. There was only one severe AE case (spondylolisthesis; raloxifene/vitamin D group), unlikely to be related to trial intervention. Conclusions: Among postmenopausal women with osteoporosis or osteopenia, a fixed dose combi- nation of raloxifene 60 mg/vitamin D 800 IU showed superior efficacy in elevating serum 25(OH)D levels compared with raloxifene 60 mg alone during 16 weeks of follow-up. The safety of raloxifene/vitamin D combination was comparable to raloxifene alone.

참고문헌 (Reference)

• 1 Adami S, "Vitamin D status and response to treatment in post-menopausal osteoporosis" 20 : 239-244, 2009
• 2 Lim SK, "Vitamin D inadequacy in postmenopausal women in Eastern Asia" 24 : 99-106, 2008
• 3 Holick MF, "Vitamin D deficiency : a worldwide problem with health consequences" 87 : 1080S-1086S, 2008
• 4 Meunier PJ, "Treatment of postmenopausal women with osteoporosis or low bone density with raloxifene" 10 : 330-336, 1999
• 5 Didriksen A, "The serum 25-hydroxyvitamin D response to vitamin D supplementation is related to genetic factors, BMI, and baseline levels" 169 : 559-567, 2013
• 6 Lips P, "The prevalence of vitamin D inadequacy amongst women with osteoporosis : an international epidemiological investigation" 260 : 245-254, 2006
• 7 이채진 ; 김성수 ; 서원윤 ; 김종성 ; 정진규 ; 윤석준 ; 서유리 ; 양현정, "The Effect of Education and Vitamin D Supplementation on the Achievement of Optimal Vitamin D Level in Korean Postmenopausal Women" 대한골대사학회 26 (26): 193-199, 2019
• 8 Gambacciani M, "Selective estrogen modulators in menopause" 65 : 621-630, 2013
• 9 Clemett D, "Raloxifene : a review of its use in postmenopausal osteoporosis" 60 : 379-411, 2000
• 10 Eastell R, "Pharmacological management of osteoporosis in postmenopausal women : An endocrine society* clinical practice guideline" 104 : 1595-1622, 2019
• 11 Lee HW, "Pharmacokinetic drug interaction between raloxifene and cholecalciferol in healthy volunteers" 11 : 623-631, 2022
• 12 최한석 ; 민용기 ; 변동원 ; 한명훈 ; 김경민 ; 김범준 ; 오기원, "Korean Society for Bone and Mineral Research Task Force Report: Perspectives on Intermittent High-dose Vitamin D Supplementation" 대한골대사학회 24 (24): 141-145, 2017
• 13 Delmas PD, "Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis : four-year results from a randomized clinical trial" 87 : 3609-3617, 2002
• 14 김광준 ; 임승길 ; 민용기 ; 고정민 ; 정윤석 ; 김경민 ; 변동원 ; 김인주 ; 김미경 ; 김성수 ; 민경완 ; 한기옥 ; 박형무 ; 신찬수 ; 최성희 ; 박종숙 ; 정동진 ; 목지오 ; 백홍선 ; 문성환 ; 김용수, "Efficacy and Safety of Weekly Alendronate Plus Vitamin D3 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial" 연세대학교의과대학 55 (55): 715-724, 2014
• 15 Morii H, "Effect of raloxifene on bone mineral density and biochemical markers of bone turnover in Japanese postmenopausal women with osteoporosis : results from a randomized placebo-controlled trial" 14 : 793-800, 2003
• 16 김경민 ; 정호연 ; 최한석 ; 최미자, "Calcium and Vitamin D Supplementations: 2015 Position Statement of the Korean Society for Bone and Mineral Research" 대한골대사학회 22 (22): 143-149, 2015
• 17 Camacho PM, "American association of clinical endocrinologists/American college of endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update" 26 : 1-46, 2020
• 18 Gorai I, "Alfacalcidol-supplemented raloxifene therapy has greater bone-sparing effect than raloxifene-alone therapy in postmenopausal Japanese women with osteoporosis or osteopenia" 30 : 349-358, 2012
• 19 Autier P, "A systematic review : influence of vitamin D supplementation on serum 25-hydroxyvitamin D concentration" 97 : 2606-2613, 2012