{"title":"一项关于雷洛昔芬加胆钙化醇与单用胆钙化醇对绝经后骨质疏松妇女骨质密度影响的随机对照试验。","authors":"Sungjae Shin, Namki Hong, Yumie Rhee","doi":"10.1093/jbmrpl/ziae073","DOIUrl":null,"url":null,"abstract":"<p><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 (-2.5 < lowest T-score < -1.0). Participants were randomly assigned to receive raloxifene 60 mg/day plus cholecalciferol 800 IU/day (RalD) or cholecalciferol 800 IU/day (VitD) for 48 wk. At baseline, mean age (63.1 ± 6.8 yr) 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 wk, the RalD group showed a greater increase in lumbar spine BMD (RalD vs. VitD; 2.6% vs. -0.6%, <i>P</i> =.005) and attenuated the total hip BMD loss (-0.3% vs. -2.9%, <i>P</i> = .003). The effect of raloxifene on the lumbar spine remained significant after adjustment for age, BMI, baseline BMD T-score, and other covariates (adjusted β: +3.05 vs. VitD, <i>P</i> =.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 ≤ -2.0). 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. <i>Clinical trial registration</i>: The trial was registered with ClinicalTrials.gov (NCT05386784).</p>","PeriodicalId":14611,"journal":{"name":"JBMR Plus","volume":"8 7","pages":"ziae073"},"PeriodicalIF":3.4000,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11208723/pdf/","citationCount":"0","resultStr":"{\"title\":\"A randomized controlled trial of the effect of raloxifene plus cholecalciferol versus cholecalciferol alone on bone mineral density in postmenopausal women with osteopenia.\",\"authors\":\"Sungjae Shin, Namki Hong, Yumie Rhee\",\"doi\":\"10.1093/jbmrpl/ziae073\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><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 (-2.5 < lowest T-score < -1.0). Participants were randomly assigned to receive raloxifene 60 mg/day plus cholecalciferol 800 IU/day (RalD) or cholecalciferol 800 IU/day (VitD) for 48 wk. At baseline, mean age (63.1 ± 6.8 yr) 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 wk, the RalD group showed a greater increase in lumbar spine BMD (RalD vs. VitD; 2.6% vs. -0.6%, <i>P</i> =.005) and attenuated the total hip BMD loss (-0.3% vs. -2.9%, <i>P</i> = .003). The effect of raloxifene on the lumbar spine remained significant after adjustment for age, BMI, baseline BMD T-score, and other covariates (adjusted β: +3.05 vs. VitD, <i>P</i> =.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 ≤ -2.0). 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. <i>Clinical trial registration</i>: The trial was registered with ClinicalTrials.gov (NCT05386784).</p>\",\"PeriodicalId\":14611,\"journal\":{\"name\":\"JBMR Plus\",\"volume\":\"8 7\",\"pages\":\"ziae073\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-05-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11208723/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JBMR Plus\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/jbmrpl/ziae073\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JBMR Plus","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/jbmrpl/ziae073","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0
摘要
雷洛昔芬可增加骨质疏松症患者腰椎骨矿物质密度(BMD),降低脊椎骨折风险。然而,很少有前瞻性临床试验研究其对绝经后骨质疏松症女性的疗效。本研究调查了雷洛昔芬对绝经后骨质疏松症妇女的疗效。研究人员对 112 名绝经后骨质疏松症妇女进行了一项随机、开放标签、前瞻性、单中心试验。骨质疏松症是根据腰椎、股骨颈或全髋骨最低 BMD T 评分(-2.5,P =.005)来定义的,并可减轻全髋骨 BMD 损失(-0.3% 对 -2.9%,P = .003)。调整年龄、体重指数、基线 BMD T 评分和其他协变量后,雷洛昔芬对腰椎的影响仍然显著(调整后 β:+3.05 vs. VitD,P =.015)。在亚组分析中,RalD 组与 VitD 组之间腰椎 BMD 的差异在严重骨质疏松症组(最低 T 评分≤-2.0)中表现明显。与单用胆钙化醇相比,雷洛昔芬加胆钙化醇能明显改善腰椎BMD,减轻髋关节BMD的总损失,对严重骨质疏松症患者的效果更显著。临床试验注册:该试验已在 ClinicalTrials.gov 注册(NCT05386784)。
A randomized controlled trial of the effect of raloxifene plus cholecalciferol versus cholecalciferol alone on bone mineral density in postmenopausal women with osteopenia.
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 (-2.5 < lowest T-score < -1.0). Participants were randomly assigned to receive raloxifene 60 mg/day plus cholecalciferol 800 IU/day (RalD) or cholecalciferol 800 IU/day (VitD) for 48 wk. At baseline, mean age (63.1 ± 6.8 yr) 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 wk, the RalD group showed a greater increase in lumbar spine BMD (RalD vs. VitD; 2.6% vs. -0.6%, P =.005) and attenuated the total hip BMD loss (-0.3% vs. -2.9%, P = .003). The effect of raloxifene on the lumbar spine remained significant after adjustment for age, BMI, baseline BMD T-score, and other covariates (adjusted β: +3.05 vs. VitD, P =.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 ≤ -2.0). 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. Clinical trial registration: The trial was registered with ClinicalTrials.gov (NCT05386784).