预约演示
更新于：2026-10-03
Eldecalcitol
艾地骨化醇
更新于：2026-10-03
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 日本 (2011-01-21), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C30H50O5 |
InChIKeyFZEXGDDBXLBRTD-AYIMTCTASA-N |
CAS号104121-92-8 |
关联
78
项与 艾地骨化醇 相关的临床试验NCT07063797
Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
CTR20255171
中国健康研究参与者空腹及餐后状态下单次口服艾地骨化醇片的一项单中心、开放、随机、单剂量、两周期、两序列、自身交叉生物等效性试验
CTR20253016
艾地骨化醇软胶囊在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究
100 项与 艾地骨化醇 相关的临床结果
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100 项与 艾地骨化醇 相关的转化医学
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100 项与 艾地骨化醇 相关的专利（医药）
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299
项与 艾地骨化醇 相关的文献（医药）2026-10-01TISSUE & CELL
Eldecalcitol enhances osteo/odontogenic differentiation and mineralized matrix formation via redox modulation in human dental pulp stem cells
Article
作者: López-García, Sergio ; Rodríguez-Lozano, Francisco Javier ; Rodríguez-González, Pablo ; Menchón-Pérez, María José ; García-Bernal, David ; Pérez-Oliva, Ana Belén
OBJECTIVE:
This study investigated the effects of eldecalcitol (ELD), a synthetic analog of vitamin D3, with immunomodulatory and osteogenic modulatory properties, on the biological behavior of human dental pulp stem cells (hDPSCs) in vitro. Specifically, this study aimed to evaluate the influence of ELD on cell viability, oxidative stress responses, migratory capacity, osteo/odontogenic differentiation, and mineralization potential, with particular attention to elucidating the interplay between redox modulation and the regenerative properties of hDPSCs.
METHODS:
hDPSCs were treated with different concentrations of ELD and evaluated at multiple time points. Cell viability was evaluated using the MTT assay, while apoptosis and intracellular reactive oxygen species (ROS) production were analyzed by flow cytometry using Annexin V/7-AAD and CM-H2DCFDA staining, respectively. Cell migration was assessed through wound-healing assays, and cytoskeletal organization was examined by F-actin phalloidin staining. Osteo/odontogenic differentiation was analyzed by real-time quantitative polymerase chain reaction (RT-qPCR) by measuring the expression levels of alkaline phosphatase (ALP), collagen type I alpha 1 chain (COL1A1), osteonectin (ON), and bone sialoprotein (BSP). Mineralized matrix formation was assessed by Alizarin Red S staining. Statistical analyses were performed using ANOVA followed by appropriate post hoc tests (p < 0.05).
RESULTS:
ELD exhibited dose-dependent effects on hDPSC behaviour. Lower concentrations (10⁻5, 10-6 and 10⁻7 M) preserved cell viability, maintained redox balance, enhanced migratory capacity, and promoted a well-organized cytoskeletal architecture. By contrast, higher concentrations (10⁻⁴ M) increased ROS production and apoptosis, ultimately compromising cellular performance. At the transcriptional level, ELD significantly upregulated key osteogenic markers, with early induction of ALP and COL1A1 followed by subsequent increases in ON and BSP expression (p < 0.05). These molecular changes were associated with a significant increase in calcium-rich nodule formation, confirming enhanced mineralization at biologically favourable concentrations. Overall, ELD demonstrated dose-dependent regulatory effects on hDPSC and may represent a promising strategy for regenerative endodontic therapy.
CONCLUSIONS:
ELD promotes osteo/odontogenic differentiation and mineralized matrix formation in hDPSCs through dose-dependent modulation of redox balance and cellular functionality. Together, these findings underscore the presence of a defined therapeutic concentration window and support the potential use of ELD as a biomodulatory molecule in regenerative endodontic approaches.
2026-10-01Clinical and Experimental Nephrology
Eldecalcitol in older adults with kidney vulnerability: a narrative review of risk-based use, dose adjustment, and monitoring
Review
作者: Furuto, Yoshitaka ; Shibuya, Yuko ; Yoshino, Daiki ; Sato, Dai ; Namikawa, Akio
Eldecalcitol is an active vitamin D analogue used for osteoporosis in Japan. Its usual dose is 0.75 μg/day, but calcium-related adverse effects can become clinically important when reduced kidney reserve, frailty, low body weight, poor intake, dehydration risk, interacting medicines, or unreliable follow-up coexist. This narrative review synthesizes trial, post-marketing, pharmacovigilance, and real-world monitoring evidence to define a practical safety framework. Eldecalcitol reduces vertebral fractures compared with alfacalcidol, whereas hip-fracture protection has not been established; therefore, its role should be determined by the patient's fracture pattern, treatment objective, kidney function, and availability of alternatives with established hip-fracture efficacy. Before treatment, clinicians should confirm osteoporosis, measure total serum calcium with albumin (and use albumin-adjusted calcium where appropriate), and assess serum creatinine with reported eGFR. Primary hyperparathyroidism and other metabolic bone disorders should be considered when baseline findings are atypical. Creatinine-based eGFR is the pragmatic minimum standard; cystatin C is most useful when low muscle mass or discordance makes kidney reserve uncertain. A lower dose of 0.5 μg/day is a dose-adjustment or re-challenge option after calcium normalization; it does not remove the need for calcium surveillance and clinical reassessment, and long-term fracture-prevention efficacy at that dose is not established. Eldecalcitol should be withheld during poor intake, dehydration, or acute illness and reconsidered when calcium rises or kidney function deteriorates. Safe use therefore requires risk-based selection rather than passive routine-dose prescribing, planned biochemical follow-up, and explicit treatment reassessment.
2026-08-30JBMR Plus
Repeated romosozumab with short-term ibandronate sequencing in high-risk osteoporosis: a retrospective single-center cohort study
Article
作者: Maeda, Mutsuhiro ; Maeda, Hiroyuki ; Maeda, Takahiro
Abstract:
Long-term real-world evidence on repeated romosozumab treatment remains limited. This retrospective single-center cohort included 68 patients who initiated treatment between April 2020 and April 2026. Nineteen patients discontinued during the 5-yr observation period, and 49 completed follow-up and formed the longitudinal analytical cohort. Patients received romosozumab for 12 mo followed by oral ibandronate 100 mg once monthly for 3 mo before reassessment for another course. All patients received eldecalcitol 0.75 μg daily. Recorded LS and femoral young adult mean (YAM) values, bone turnover markers, numerical rating scale scores, persistence, fractures, and prespecified safety events were evaluated. Longitudinal outcomes were analyzed using linear mixed-effects models with a patient-level random intercept. Lumbar spine YAM increased from 73.3% at baseline to 92.9% at 5 yr, with a model-estimated change of 19.6 percentage points (95% CI, 17.9-21.3; p < .001). Femoral YAM increased from 66.2% to 76.1%, with a change of 9.9 percentage points (95% CI, 9.2-10.5; p < .001). Numerical rating scale scores decreased from 8.9 to 1.4, with an estimated change of −7.5 (95% CI, −7.9 to −7.1; p < .001). Interval-based treatment persistence was 72.1% at 5 yr (95% CI, 59.8%-81.2%). One recurrent vertebral fracture was recorded, whereas no cardiovascular events, hypocalcemia, osteonecrosis of the jaw, or atypical femoral fractures were recorded. Repeated courses were accompanied by longitudinal improvements in recorded skeletal measures and bone turnover markers. Because this was an uncontrolled retrospective study and patient-level baseline data for the 19 patients who discontinued were unavailable in the analytical dataset, the findings should be considered descriptive and hypothesis-generating.
100 项与 艾地骨化醇 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 骨质疏松症 | 日本 | 2011-01-21 |
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10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 原发性骨质疏松症 | 临床3期 | 中国 | 2015-08-31 | |
| 骨质疏松性骨折 | 临床3期 | - | 2004-09-01 |
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临床结果
临床结果
适应症
分期
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临床4期 | 100 | 觸選鏇構築襯糧積獵構(糧積鏇鏇蓋餘鑰鹽積齋) = 繭範壓網鏇窪餘淵顧糧 遞憲築膚憲構糧醖選鹽 (鑰遞餘鹹夢顧繭廠築觸 ) 更多 | 积极 | 2025-04-10 | |||
Denosumab 60 mg + Vitamin D (800 IU daily) + Calcium supplementation (600 mg daily) | 窪糧鏇衊鬱簾積糧願簾(廠齋鹽鏇鹽壓窪醖築鏇) = 蓋夢艱範醖艱繭網衊積 積選範襯繭憲繭夢鹹膚 (選願遞醖鏇廠觸憲製壓 ) | ||||||
临床4期 | 葡萄糖耐受不良 serum 25-hydroxyvitamin D | 1,256 | 選蓋壓鏇窪糧鬱窪鹽夢(艱夢鏇壓鹹鏇艱鹽觸鏇) = 襯鏇願鏇膚顧膚蓋鬱網 鏇壓鹽壓膚襯醖積夢膚 (獵鑰鏇壓製願鹹顧願鏇 ) 更多 | 不佳 | 2018-10-04 | ||
Placebo | 選蓋壓鏇窪糧鬱窪鹽夢(艱夢鏇壓鹹鏇艱鹽觸鏇) = 窪憲餘積繭獵襯遞鏇築 鏇壓鹽壓膚襯醖積夢膚 (獵鑰鏇壓製願鹹顧願鏇 ) 更多 | ||||||
临床3期 | 1,054 | 鬱觸鏇觸憲網淵選窪觸(夢鏇獵蓋鏇積窪鬱鑰積) = 製選廠簾壓築壓願夢醖 繭餘鏇醖鬱構鏇窪衊繭 (鹽顧膚糧衊餘艱廠餘觸, 0.56 ~ 0.97) | 积极 | 2011-10-01 | |||
鬱觸鏇觸憲網淵選窪觸(夢鏇獵蓋鏇積窪鬱鑰積) = 顧醖網膚繭廠蓋窪選鏇 繭餘鏇醖鬱構鏇窪衊繭 (鹽顧膚糧衊餘艱廠餘觸 ) |
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