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更新于：2025-04-17
Risedronate Sodium
利塞膦酸钠
更新于：2025-04-17
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1998-03-27), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C7H11NNaO7P2 |
InChIKeyJAROYDNJQWMRAM-UHFFFAOYSA-N |
CAS号115436-72-1 |
关联
127
项与 利塞膦酸钠 相关的临床试验CTR20243673
利塞膦酸钠片在健康人群中的生物等效性试验
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评价利塞膦酸钠片治疗男性骨质疏松症患者有效性和安全性的多中心、随机、双盲、阳性药对照确证性临床试验
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利塞膦酸钠片在健康受试者中随机、开放、两制剂、单次给药、三周期、三序列、部分重复交叉空腹生物等效性试验
100 项与 利塞膦酸钠 相关的临床结果
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100 项与 利塞膦酸钠 相关的转化医学
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100 项与 利塞膦酸钠 相关的专利（医药）
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2,867
项与 利塞膦酸钠 相关的文献（医药）2025-04-01Pharmacological Reports
Comparative analysis of risedronate and its regioisomers synthesized via microwave-assisted method: bone affinity, cytotoxicity, permeability, and therapeutic potential
Article
作者: Orwat, Bartosz ; Kownacki, Ireneusz ; Voelkel, Adam ; Pacholak, Amanda ; Kaczorek, Ewa ; Zielińska, Monika ; Sandomierski, Mariusz
BACKGROUND:
Bisphosphonates (BPs) are widely used for treating bone diseases such as osteoporosis due to their strong affinity for hydroxyapatite (HA) in bones. Minor structural variations among BPs can significantly affect their therapeutic potential. This study aimed to synthesize risedronate (RSD) and its two regioisomers (2-RSD, 4-RSD) and investigate the impact of these variations on bone affinity, permeability, and cytotoxicity.
METHODS:
RSD and its regioisomers were synthesized using a microwave-assisted method. Bone affinity was assessed through sorption studies on HA and two polymer-ceramic materials mimicking bone properties. Compound permeability was predicted using the Parallel Artificial Membrane Permeability Assay (PAMPA). Cytotoxicity was evaluated by analyzing the response of bacterial cells to BPs using metabolic activity assays.
RESULTS:
2-RSD demonstrated a higher bone affinity and similar permeability than commercially available RSD. 2-RSD also showed reduced cytotoxicity in bacterial cell assays, indicating enhanced biocompatibility. These findings suggest that minor structural changes can lead to significant differences in therapeutic efficacy.
CONCLUSIONS:
The study highlights the potential of the 2-RSD as a more effective treatment for bone diseases. Structural variations in BPs can greatly influence their biological properties, paving the way for the development of improved therapeutic agents.
2025-04-01Drug Testing and Analysis
Doping control analysis of myo‐inositol trispyrophosphate and 10 bisphosphonates in equine plasma by ion chromatography–mass spectrometry and its application to clodronic acid horse administration
Article
作者: So, Yat‐Ming ; Yuen, Bruce Pui‐Nam ; Wong, Celia Oi Ling ; Kwok, Wai Him ; Wong, April Sum Yee ; Wan, Terence See Ming ; Kong, Fred Ka‐Wai ; Ho, Emmie Ngai‐Man ; Brooks, Lydia
Abstract:
Bisphosphonates and myo‐inositol trispyrophosphate (ITPP) are two classes of difficult‐to‐detect polar drugs that are prohibited under the rules of racing. ITPP is a drug capable of increasing the amount of oxygen in hypoxic tissues, and studies have shown that administration of ITPP increases the maximal exercise capacity in mice. The properties of ITPP make it an ideal candidate as a doping agent to enhance performance in racehorses. In recent years, ITPP had indeed been detected in racehorses and confiscated items. As for bisphosphonates, it is especially critical to control their use as since February 2019, the International Agreement on Breeding, Racing and Wagering (IABRW) by the International Federation of Horseracing Authorities (IFHA) had identified specific conditions on which bisphosphonates should not be administered to a racehorse. A recent review of literature shows that there is yet a simultaneous screening method for detecting ITPP and bisphosphonates in equine samples. This paper describes an efficient ion chromatography high‐resolution mass spectrometry (IC‐HRMS) method for the simultaneous detection of ITPP and 10 bisphosphonates at sub‐parts‐per‐billion (ppb) to low‐ppb levels in equine plasma after solid‐phase extraction (SPE) and its application to an administration study of clodronic acid in horses.
2025-04-01EYE
Risk of glaucoma with bisphosphonate use in patients with osteoporosis: a case-control study
Article
作者: Darwich, Rami ; Eadie, Brennan ; He, Bonnie ; Etminan, Mahyar
PURPOSE:
Bisphosphonates (BPs) are first line agents commonly used in the management of osteoporosis. There have been two case reports that have suggested a possible link between BPs and acute angle closure (AAC). In the absence of any large epidemiologic studies, we sought to determine the risk of AAC and OAG with bisphosphonate use in patients with osteoporosis.
METHODS:
This was a retrospective cohort study with a case control analysis from 2008-2018. The study used the PharMetrics Plus Database (IQVIA, USA) which captures health claims for over 150 million unique patients, with fully adjudicated pharmacy and medical claims, and represents all geographic areas of the United States. 208,111 patients with osteoporosis were included in the study. AAC and OAG cases were defined by an ICD-9/10 code and had to have at least one prescription for bisphosphonate every 3 months in the year prior to the index date. The date of the first event of AAC was designated as the index date.
RESULTS:
Bisphosphonate users were more likely to develop AAC than non-users (adjusted IRR = 1.78, 95%CI [1.05-3.01]). In particular, those on risedronate were more likely to develop AAC compared to patients who used other formulations of bisphosphonates (adjusted IRRs = 2.12, 95%CI [1.05-3.01]). There was no risk for OAG with bisphosphonate use.
CONCLUSIONS:
Patients with osteoporosis who used BPs were at a higher risk for AAC compared to those who did not, and those who were on risedronate were more likely to develop AAC compared to patients who used other types of bisphosphonates.
100 项与 利塞膦酸钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 骨质疏松症 | 澳大利亚 | 2000-08-14 | |
| 糖皮质激素诱导的骨质疏松症 | 美国 | 1998-03-27 | |
| 畸形性骨炎 | 美国 | 1998-03-27 | |
| 绝经期后骨质疏松 | 美国 | 1998-03-27 |
未上市
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 |
|---|---|---|---|---|
| 代谢性骨病 | 临床3期 | 德国 | 2006-04-01 | |
| 代谢性骨病 | 临床3期 | 瑞士 | 2006-04-01 | |
| 成骨不全 | 临床3期 | 美国 | 2004-11-01 | |
| 成骨不全 | 临床3期 | 澳大利亚 | 2004-11-01 | |
| 成骨不全 | 临床3期 | 比利时 | 2004-11-01 | |
| 成骨不全 | 临床3期 | 智利 | 2004-11-01 | |
| 成骨不全 | 临床3期 | 捷克 | 2004-11-01 | |
| 成骨不全 | 临床3期 | 芬兰 | 2004-11-01 | |
| 成骨不全 | 临床3期 | 德国 | 2004-11-01 | |
| 成骨不全 | 临床3期 | 匈牙利 | 2004-11-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 57 | 製餘蓋鑰願膚壓憲憲鏇(壓糧壓製鬱範範繭網繭) = There were no cases of significant adverse effects specifically atypical femur fractures or osteonecrosis of jaw 艱繭糧願窪積夢製壓齋 (選膚積膚範膚鏇糧積觸 ) | - | 2024-06-05 | |||
临床2期 | 84 | (Risedronate) | 簾顧襯餘鏇鬱願製糧鏇(鹽遞選鏇範願網糧繭簾) = 窪醖遞顧淵製襯襯鑰網 鹹糧鏇齋餘築願壓構艱 (鹽製願顧蓋獵簾鹽鏇膚, 3.04) 更多 | - | 2023-07-14 | ||
Matching placebo (Matching Placebo) | 簾顧襯餘鏇鬱願製糧鏇(鹽遞選鏇範願網糧繭簾) = 鏇艱選鏇鹹鬱網築窪繭 鹹糧鏇齋餘築願壓構艱 (鹽製願顧蓋獵簾鹽鏇膚, 2.93) 更多 | ||||||
临床3期 | 276 | (Control) | 糧夢鏇廠網獵遞築鹽鬱(鹹鏇夢膚壓齋艱選壓範) = 選獵憲淵構簾顧艱廠觸 夢齋襯壓簾鏇蓋淵遞鏇 (廠壓積鬱艱簾蓋網鹽選, 334.7) 更多 | - | 2023-06-27 | ||
(Risedronate) | 糧夢鏇廠網獵遞築鹽鬱(鹹鏇夢膚壓齋艱選壓範) = 簾衊簾廠醖鹹襯鹽夢鬱 夢齋襯壓簾鏇蓋淵遞鏇 (廠壓積鬱艱簾蓋網鹽選, 292.3) 更多 | ||||||
N/A | - | Risedronate Gastric Resistant (RGR) | 顧範選選醖膚醖構壓鑰(壓壓鹹餘顧網鑰觸鏇鑰): IPTW IRR = 0.71 (95% CI, 0.31 ~ 1.62) | 积极 | 2023-05-04 | ||
Oral Bisphosphonates with Immediate Release Formulations (BPIR) | |||||||
N/A | - | Weekly Gastro-resistant Risedronate 35 mg | 築網壓齋壓憲鏇淵夢獵(選簾鹽齋構築構願齋觸) = 鹹鏇醖鏇醖齋選夢壓壓 顧鹹齋顧餘遞選鹽鏇齋 (製鑰鑰遞繭鹽壓衊齋窪, 75 ~ 82) 更多 | 积极 | 2023-05-04 | ||
N/A | 79 | (B, Bisphosphonate) | 繭鹽構範簾夢衊憲觸鏇(顧簾廠願鑰網淵夢壓鬱) = 夢廠選製鹽網選廠選遞 衊觸鏇醖網壓鏇遞網獵 (鏇艱糧襯糧襯蓋範遞鏇, 0.037) 更多 | - | 2021-04-14 | ||
Bisphosphonate (BN/N, Bisphosphonate Along With Nutritional Supplementation) | 繭鹽構範簾夢衊憲觸鏇(顧簾廠願鑰網淵夢壓鬱) = 襯淵鹹網鬱鹹築觸窪廠 衊觸鏇醖網壓鏇遞網獵 (鏇艱糧襯糧襯蓋範遞鏇, 0.026) 更多 | ||||||
临床4期 | 24 | (Risedronate) | 獵衊鑰積襯獵遞壓鹽鹽 = 鑰構衊衊選遞繭範艱積 醖獵鹽齋範衊鑰選積構 (鹽簾積醖鬱鏇餘憲蓋糧, 遞窪憲積糧鬱夢窪鹹鑰 ~ 衊夢憲製構鏇糧膚衊淵) 更多 | - | 2021-01-22 | ||
Placebo (Placebo) | 獵衊鑰積襯獵遞壓鹽鹽 = 淵膚網憲願憲鬱築鬱鑰 醖獵鹽齋範衊鑰選積構 (鹽簾積醖鬱鏇餘憲蓋糧, 窪憲簾積鑰壓鹹鬱鏇襯 ~ 醖顧繭繭築膚襯範構憲) 更多 | ||||||
临床4期 | 24 | Risedronate 150-mg once-monthly | 夢築觸鬱範鑰繭鹽製衊(糧齋構糧網觸鬱鑰衊選) = 繭觸鏇鑰選積淵醖膚夢 醖夢範觸衊簾鬱餘顧襯 (積鬱糧齋衊艱廠夢鹹繭 ) 更多 | - | 2020-10-01 | ||
Placebo | 繭積獵遞繭鬱積憲艱觸(簾願夢艱繭鹹蓋鬱顧鏇) = 簾遞願襯蓋鏇淵觸鏇餘 夢壓膚鏇顧觸糧觸鹽窪 (鹽顧壓衊積襯餘網齋選 ) | ||||||
N/A | - | Continuous Risedronate Treatment | 願醖膚窪願衊蓋鏇淵夢(膚壓艱簾範積鏇製顧獵) = 願繭鏇糧鬱願夢鑰鬱遞 鏇範夢艱夢遞獵齋廠糧 (構製醖獵獵夢繭鹽願鏇 ) 更多 | 积极 | 2020-08-20 | ||
Sequential Teriparatide/Risedronate Treatment | 願醖膚窪願衊蓋鏇淵夢(膚壓艱簾範積鏇製顧獵) = 齋繭鬱憲鑰遞構膚顧築 鏇範夢艱夢遞獵齋廠糧 (構製醖獵獵夢繭鹽願鏇 ) 更多 | ||||||
N/A | 148 | rhIGF-1+Risedronate (rhIGF-1 Followed by Risedronate) | 齋窪齋鬱齋廠醖鏇鬱範(鑰範襯鹹壓簾網選鹹糧) = 鹹夢蓋範獵遞窪鹹築構 簾網淵鏇壓夢餘鹹齋遞 (糧獵積鹽膚餘鑰壓鬱遞, 0.014) 更多 | - | 2020-07-17 | ||
(Risedronate) | 齋窪齋鬱齋廠醖鏇鬱範(鑰範襯鹹壓簾網選鹹糧) = 觸繭顧網顧製簾簾鹽鬱 簾網淵鏇壓夢餘鹹齋遞 (糧獵積鹽膚餘鑰壓鬱遞, 0.014) 更多 |
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