{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T20:25:36Z","timestamp":1740169536579,"version":"3.37.3"},"reference-count":19,"publisher":"Korean Society for Bone and Mineral Research","issue":"3","license":[{"start":{"date-parts":[[2022,8,31]],"date-time":"2022-08-31T00:00:00Z","timestamp":1661904000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Hanmi Pharmaceutical Co., Ltd."}],"content-domain":{"domain":["e-jbm.org"],"crossmark-restriction":true},"short-container-title":["J Bone Metab"],"published-print":{"date-parts":[[2022,8,31]]},"abstract":"<jats:p>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 university-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 raloxifene\/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\u00b16.5 ng\/mL) than in the raloxifene monotherapy (-1.7\u00b16.2 ng\/mL; P=0.0034) group. Proportions 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 combination 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.<\/jats:p>","DOI":"10.11005\/jbm.2022.29.3.155","type":"journal-article","created":{"date-parts":[[2022,9,16]],"date-time":"2022-09-16T06:55:06Z","timestamp":1663311306000},"page":"155-163","update-policy":"https:\/\/doi.org\/10.11005\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["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 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