{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T07:14:06Z","timestamp":1782285246920,"version":"3.54.5"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2024,5,30]],"date-time":"2024-05-30T00:00:00Z","timestamp":1717027200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Hanmi Pharmaceutical Co., Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,5,31]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Raloxifene increases lumbar spine bone mineral density (BMD) and lowers vertebral fracture risk in patients with osteoporosis. However, few prospective clinical trials have studied its efficacy in postmenopausal women with osteopenia. This study investigated the efficacy of raloxifene in postmenopausal women with osteopenia. An investigator-initiated, randomized, open-label, prospective, single-center trial was conducted in 112 postmenopausal women with osteopenia. Osteopenia was defined based on the lowest BMD T-score in the lumbar spine, femoral neck, or total hip (\u22122.5\u2009&amp;lt;\u2009lowest T-score\u2009&amp;lt;\u2009\u22121.0). Participants were randomly assigned to receive raloxifene 60\u00a0mg\/day plus cholecalciferol 800\u00a0IU\/day (RalD) or cholecalciferol 800\u00a0IU\/day (VitD) for 48\u00a0wk. At baseline, mean age (63.1\u2009\u00b1\u20096.8\u00a0yr) did not differ between the two groups. However, in the RalD group, mean body mass index (BMI) and baseline T-score were lower, while 25-hydroxyvitamin D level was higher. At 48\u00a0wk, the RalD group showed a greater increase in lumbar spine BMD (RalD vs. VitD; 2.6% vs. \u22120.6%, P\u2009=.005) and attenuated the total hip BMD loss (\u22120.3% vs. \u22122.9%, P\u2009=\u2009.003). The effect of raloxifene on the lumbar spine remained significant after adjustment for age, BMI, baseline BMD T-score, and other covariates (adjusted \u03b2: +3.05 vs. VitD, P\u2009=.015). In subgroup analysis, the difference in lumbar spine BMD between the RalD and VitD groups was robust in those with severe osteopenia group (lowest T-score\u2009\u2264\u2009\u22122.0). Raloxifene plus cholecalciferol significantly improved lumbar spine BMD and attenuated total hip BMD loss compared with cholecalciferol alone, with a more robust effect in severe osteopenia.<\/jats:p>\n               <jats:p>Clinical trial registration: The trial was registered with ClinicalTrials.gov (NCT05386784).<\/jats:p>","DOI":"10.1093\/jbmrpl\/ziae073","type":"journal-article","created":{"date-parts":[[2024,5,30]],"date-time":"2024-05-30T17:02:00Z","timestamp":1717088520000},"source":"Crossref","is-referenced-by-count":7,"title":["A randomized controlled trial of the effect of raloxifene plus cholecalciferol versus cholecalciferol alone on bone mineral density in postmenopausal women with osteopenia"],"prefix":"10.1093","volume":"8","author":[{"given":"Sungjae","family":"Shin","sequence":"first","affiliation":[{"name":"National Health Insurance Service Ilsan Hospital Division of Endocrinology and Metabolism, Department of Internal Medicine, , Goyang 10444, Republic of Korea"},{"name":"Yonsei University College of Medicine Department of Internal Medicine, Endocrine Research Institute, , Seoul 03722, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namki","family":"Hong","sequence":"additional","affiliation":[{"name":"Yonsei University College of Medicine Department of Internal Medicine, Endocrine Research Institute, , Seoul 03722, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumie","family":"Rhee","sequence":"additional","affiliation":[{"name":"Yonsei University College of Medicine Department of Internal Medicine, Endocrine Research Institute, , Seoul 03722, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,5,30]]},"reference":[{"issue":"8","key":"2024062706004647900_ref1","doi-asserted-by":"crossref","first-page":"1137","DOI":"10.1002\/jbmr.5650090802","article-title":"The diagnosis of osteoporosis","volume":"9","author":"Kanis","year":"1994","journal-title":"J Bone Miner Res"},{"issue":"3","key":"2024062706004647900_ref2","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1016\/j.bone.2007.11.001","article-title":"A reference standard for the description of osteoporosis","volume":"42","author":"Kanis","year":"2008","journal-title":"Bone"},{"issue":"1","key":"2024062706004647900_ref3","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1007\/s00198-018-4704-5","article-title":"European guidance for the diagnosis and management of osteoporosis in postmenopausal women","volume":"30","author":"Kanis","year":"2019","journal-title":"Osteoporos Int"},{"issue":"Suppl 4","key":"2024062706004647900_ref4","doi-asserted-by":"crossref","first-page":"1","DOI":"10.4158\/EP161435.GL","article-title":"American association of clinical endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis - 2016","volume":"22","author":"Camacho","year":"2016","journal-title":"Endocr Pract"},{"issue":"1","key":"2024062706004647900_ref5","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1016\/j.bone.2003.10.001","article-title":"Fracture incidence and association with bone mineral density in elderly men and women: the Rotterdam study","volume":"34","author":"Schuit","year":"2004","journal-title":"Bone"},{"issue":"10","key":"2024062706004647900_ref6","doi-asserted-by":"crossref","first-page":"1108","DOI":"10.1001\/archinte.164.10.1108","article-title":"Bone mineral density thresholds for pharmacological intervention to prevent fractures","volume":"164","author":"Siris","year":"2004","journal-title":"Arch Intern Med"},{"issue":"4","key":"2024062706004647900_ref7","doi-asserted-by":"crossref","first-page":"281","DOI":"10.11005\/jbm.2020.27.4.281","article-title":"Osteoporosis and osteoporotic fracture fact sheet in Korea","volume":"27","author":"Ahn","year":"2020","journal-title":"J Bone Metab"},{"issue":"25","key":"2024062706004647900_ref8","doi-asserted-by":"crossref","first-page":"2407","DOI":"10.1056\/NEJMoa1808082","article-title":"Fracture prevention with Zoledronate in older women with osteopenia","volume":"379","author":"Reid","year":"2018","journal-title":"N Engl J Med"},{"issue":"24","key":"2024062706004647900_ref9","doi-asserted-by":"crossref","first-page":"2077","DOI":"10.1001\/jama.280.24.2077","article-title":"Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the fracture intervention trial","volume":"280","author":"Cummings","year":"1998","journal-title":"JAMA"},{"issue":"13","key":"2024062706004647900_ref10","doi-asserted-by":"crossref","first-page":"1729","DOI":"10.1001\/jama.290.13.1729","article-title":"Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women's Health Initiative randomized trial","volume":"290","author":"Cauley","year":"2003","journal-title":"JAMA"},{"issue":"7","key":"2024062706004647900_ref11","doi-asserted-by":"crossref","first-page":"637","DOI":"10.1001\/jama.282.7.637","article-title":"Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. 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