{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T08:05:28Z","timestamp":1784189128261,"version":"3.55.0"},"reference-count":32,"publisher":"MDPI AG","issue":"14","license":[{"start":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T00:00:00Z","timestamp":1784160000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Chugai Pharma China Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Eldecalcitol (ELD) and denosumab are some of the most common therapeutic options for osteoporosis management. ELD effectively increases bone mineral density (BMD) in osteoporotic patients, independent of baseline vitamin D status or calcium intake. However, the efficacy of denosumab combined with either ELD or native vitamin D plus calcium in postmenopausal Chinese women with osteoporosis has not been established. Methods: In this single-center, randomized, open-label, active-controlled clinical trial, postmenopausal women with osteoporosis (defined as a BMD T-score \u2264 \u22122.5 at the lumbar spine [LS], total hip [TH], or femoral neck [FN], or low bone mass with fragility fracture history) were enrolled from Xi\u2019an Honghui Hospital in China and randomized 1:1 to two 12-month treatment regimens: the ELD group received ELD (0.75 \u03bcg orally daily) combined with denosumab (60 mg subcutaneously every 6 months), while the control group received the same denosumab regimen plus native vitamin D (800 IU orally daily) and calcium (600 mg orally daily). The primary endpoint was the 12-month percent change in LS BMD from baseline. Secondary endpoints included changes in FN- and TH-BMD from baseline, bone turnover markers, serum parathyroid hormone, quality of life, and the incidence of new fractures. Results: Of the 100 randomized participants, 45 in the ELD group and 46 in the control group were included in the efficacy analysis. After 12 months of treatment, LS-BMD increased significantly in both groups (both p &lt; 0.05), with a greater increase in the ELD group than in the control group (6.75% vs. 4.99%), yielding a statistically significant between-group least-squares mean difference of 1.75% (95% CI, 0.10 to 3.41; p = 0.038). The reduction in serum \u03b2-CTX was significantly smaller in the ELD group than in the control group at 3 months (91.00% vs. 93.62%, p = 0.002), with no significant between-group differences thereafter. Seven fractures were reported (one non-vertebral in the ELD group; one vertebral and five non-vertebral in the control group). No significant between-group differences in FN- or TH-BMD, quality of life, or overall adverse event rates were observed. Both regimens were generally well-tolerated, without clinically meaningful calcium-related safety signals. Conclusions: Combination therapy with denosumab and eldecalcitol improved LS-BMD more effectively than denosumab with native vitamin D and calcium in postmenopausal Chinese women with osteoporosis. Clinical trial number: ClinicalTrials.gov identifier NCT05884372, registered on 1 June 2023.<\/jats:p>","DOI":"10.3390\/jcm15145570","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T06:49:36Z","timestamp":1784184576000},"page":"5570","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of Efficacy and Safety of Denosumab with Eldecalcitol or Native Vitamin D in Postmenopausal Chinese Women with Osteoporosis (ESCORT): A Randomized Controlled Trial"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8805-0066","authenticated-orcid":false,"given":"Yuhong","family":"Zeng","sequence":"first","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qinghua","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiancheng","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingmei","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maohong","family":"Che","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuhan","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Osteoporosis, Honghui Hospital, Xi\u2019an Jiaotong University, Xi\u2019an 710054, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2003","DOI":"10.1016\/S0140-6736(25)01385-6","article-title":"Osteoporosis","volume":"406","author":"Ye","year":"2025","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"894","DOI":"10.1001\/jama.2025.6003","article-title":"Osteoporosis: A review","volume":"334","author":"Morin","year":"2025","journal-title":"JAMA"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1979","DOI":"10.1056\/NEJMcp2307353","article-title":"Postmenopausal osteoporosis","volume":"389","author":"Walker","year":"2023","journal-title":"N. 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