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更新于：2025-02-15
Risedronate Sodium
利塞膦酸钠
更新于：2025-02-15
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
CTR20241113
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
CTR20240228
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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2,870
项与 利塞膦酸钠 相关的文献（医药）2025-02-01Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology
Evaluation and analysis of efficacy in bisphosphonate treatment of chronic nonbacterial osteomyelitis.
Article
作者: Wang, Jianli ; Yu, Zhujun ; Li, Dandan ; Nie, Cheng ; Zou, Zixin
OBJECTIVES:
This study aimed to analyze the influence of drug factors on the efficacy of bisphosphonate for chronic nonbacterial osteomyelitis to provide a reference for clinical treatment and promote clinical rational drug use by evaluation of effectiveness and safety of bisphosphonate treatment of chronic nonbacterial osteomyelitis.
METHODS:
Literature on the treatment of chronic nonbacterial osteomyelitis by using bisphosphonate was collected and analyzed from PubMed, Medline, Embase, Cochrane, ISI Web of Knowledge, CNKI, VIP, and Wanfang databases.
RESULTS:
A total of 489 cases were collected, with an average complete response rate of clinical presentation, laboratory tests and imaging findings of 80.37%, 80.56% and 79.22%, respectively. Except for opadronate, risedronate, ibandronate, pamidronate, alendronate, neidronate and zoledronate showed good efficacy, and the average complete response rates were 100%, 100%, 81.64%, 87.50%, 69.23% and 69.23%, respectively.The study found that in the pamidronate group, the average complete response rate of 0.5-1 mg/kg (maximum single dose≤60 mg) subgroup and the frequency of administration once every 3 months subgroup were better than other subgroups.
CONCLUSIONS:
Bisphosphonate could be used to treat chronic nonbacterial osteomyelitis, which of efficacy were affected by different drug types, dose and frequency of administration. The optimal dose and frequency of administration of pamidronate were 0.5-1 mg/kg (maximum single dose≤60 mg) and once every 3 months, respectively.
2025-02-01OSTEOPOROSIS INTERNATIONAL
Bisphosphonate drug holidays in osteoporosis according to fracture risk profile
Article
作者: Lopez, L. ; Aguado, P. ; Hernandez, B. ; Guanabens, N. ; Panero, B. ; Gomez, I. ; Ros, I. ; Casado, E. ; Gifre, L. ; Florez, H. ; for the OsteoResSer Working Group of the Spanish Society of Rheumatology ; Salmoral, Asuncion ; Aguilar, F. J. ; Barcelo, M. ; Grana, J. ; Peris, P. ; Pascual Pastor, M. ; Grados, D. ; Cerda, D. ; Costa, E. ; Lopez Medina, C. ; Garcia, S. ; Martinez Ferrer, A.
OBJECTIVE:
The optimal length of bisphosphonate discontinuation is unknown, as is the type of patient who could benefit from this approach. The objectives of the study were to analyze, in clinical practice, the incidence of fractures and associated risk factors, changes in bone mineral density (BMD) and bone turnover markers (BTMs) after discontinuation of bisphosphonates.
METHODS:
This observational retrospective study included 264 patients from 14 Spanish rheumatology departments. Postmenopausal women or men with osteoporosis received alendronate or risedronate for ≥ 5 years or zoledronate for ≥ 3 years and had discontinued treatment for ≥ 1 year or ≥ 2 years, respectively. Spinal X-rays were obtained before discontinuation and in suspected clinical vertebral fracture during follow-up. BMD and BTMs were determined before discontinuation and at different time points.
RESULTS:
The mean discontinuation time was 2.7 (± 6.7) years. Thirty-two patients (12.3%) had 36 fractures, mainly clinical vertebral fractures. The main risk factor for fracture was a high-risk profile (femoral neck T-score ≤ -2.5 and/or a history of fracture and/or multiple fractures [≥ 5 years]) before discontinuation. At 12 months, 10.41% of patients with high-risk profile experienced a fracture, being 0.8% and 1.08% in moderate- and low-risk patients, respectively. Significant BMD loss at the femoral neck and total hip was detected, with duration of discontinuation being the key factor. PINP was the marker with the greatest changes.
CONCLUSIONS:
We identified a profile of patients with osteoporosis who should not discontinue bisphosphonates, owing to the possibility of fractures, especially vertebral, which are already evident the first year after discontinuation.
2025-01-01Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association
Anti-osteoporotic drug efficacy for periprosthetic bone loss after total hip arthroplasty: A systematic review and network meta-analysis
Review
作者: Miyoshi, Kota ; Tanaka, Takeyuki ; Koizumi, Yasuhiko ; Shiroshita, Akihiro ; Kataoka, Yuki ; Yamamoto, Norio ; Hatano, Masaki ; Tanaka, Sakae ; Kawabata, Kensuke
BACKGROUND:
Periprosthetic bone loss following total hip arthroplasty (THA) threatens prosthesis stability. This systematic review and network meta-analysis aimed to compare the efficacy of anti-osteoporotic drugs for measures of hip function according to functional outcomes, periprosthetic femoral bone mineral density loss in each Gruen zone, and revision surgery after THA.
METHODS:
The systematic search of six literature databases was conducted in December 2021 in accordance with PRISMA guidelines. Adult participants who underwent primary THA were included. A random-effects network meta-analysis was performed within a frequentist framework, and the confidence in the evidence for each outcome was evaluated using the CINeMA tool, which assessed the credibility of results from the network meta-analysis. We included 22 randomized controlled trials (1243 participants) comparing the efficacy and safety of bisphosphonates (including etidronate, clodronate, alendronate, risedronate, pamidronate, and zoledronate), denosumab, selective estrogen receptor modulator, teriparatide, calcium + vitamin D, calcium, and vitamin D. We defined the period for revision surgery as the final follow-up period.
RESULTS:
Raloxifene, bisphosphonate, calcium + vitamin D, and denosumab for prosthetic hip function might have minimal differences when compared with placebos. The magnitude of the anti-osteoporotic drug effect on periprosthetic femoral bone loss varied across different Gruen zones. Bisphosphonate, denosumab, teriparatide might be more effective than placebo in Gruen zone 1 at 12 months after THA. Additionally, bisphosphonate might be more effective than placebo in Gruen zones 2, 5, 6, and 7 at 12 months after THA. Denosumab was efficacious in preventing bone loss in Gruen zones 6 and 7 at 12 months after THA. Teriparatide was likely to be efficacious in preventing bone loss in Gruen zone 7 at 12 months after THA. Raloxifene was slightly efficacious in preventing bone loss in Gruen zones 2 and 3 at 12 months after THA. Calcium was slightly efficacious in preventing bone loss in Gruen zone 5 at 12 months after THA. None of the studies reported revision surgery.
CONCLUSIONS:
Bisphosphonate and denosumab may be effective anti-osteoporotic drugs for preventing periprosthetic proximal femoral bone loss due to stress shielding after THA, particularly in cementless proximal fixation stems, which are the most commonly used prostheses worldwide.
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 |
|---|---|---|---|---|
| 前列腺癌 | 临床3期 | 加拿大 | 2007-01-01 | |
| 代谢性骨病 | 临床3期 | 加拿大 | 2006-04-01 | |
| 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 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 57 | 獵衊鹹餘顧築糧醖鬱壓(簾窪鏇鑰遞蓋觸艱鹽鹹) = There were no cases of significant adverse effects specifically atypical femur fractures or osteonecrosis of jaw 夢鹽製積遞醖鹹憲選壓 (鑰襯衊觸齋願蓋夢顧願 ) | - | 2024-06-05 | |||
临床2期 | 84 | (Risedronate) | 餘蓋齋築繭膚繭獵顧衊(衊醖積網齋觸獵膚艱糧) = 醖艱衊鑰膚齋廠糧襯襯 遞鑰繭獵膚餘餘鑰膚獵 (窪蓋糧鑰糧構齋襯鹹糧, 積顧壓壓膚範醖壓獵獵 ~ 網構鏇襯觸齋鹹觸顧蓋) 更多 | - | 2023-07-14 | ||
Matching placebo (Matching Placebo) | 餘蓋齋築繭膚繭獵顧衊(衊醖積網齋觸獵膚艱糧) = 鏇夢構鹽糧窪壓鏇觸製 遞鑰繭獵膚餘餘鑰膚獵 (窪蓋糧鑰糧構齋襯鹹糧, 膚鹽簾鬱構糧襯鏇觸鬱 ~ 積壓壓築鬱鹽糧糧觸夢) 更多 | ||||||
临床3期 | 276 | (Control) | 鏇餘艱網鹹淵壓糧窪鏇(範範遞獵艱窪簾鏇淵遞) = 憲簾膚築醖鑰艱簾網鬱 鏇製蓋遞繭網夢積積壓 (製廠餘淵憲壓願鏇願製, 鹽遞範積顧遞範齋顧襯 ~ 鬱選觸蓋網範糧夢壓範) 更多 | - | 2023-06-27 | ||
(Risedronate) | 鏇餘艱網鹹淵壓糧窪鏇(範範遞獵艱窪簾鏇淵遞) = 鏇糧齋築範遞築糧網襯 鏇製蓋遞繭網夢積積壓 (製廠餘淵憲壓願鏇願製, 鹽鹽膚淵糧鬱範繭淵繭 ~ 餘蓋積襯獵築醖鹽遞夢) 更多 | ||||||
N/A | - | Weekly Gastro-resistant Risedronate 35 mg | 願齋積積構窪繭淵醖窪(糧顧鬱夢膚鏇繭憲鹹膚) = 廠顧願簾構鑰繭範鏇製 糧構艱積願蓋廠簾鑰衊 (製簾鑰鏇夢簾製鑰積顧, 75 ~ 82) 更多 | 积极 | 2023-05-04 | ||
N/A | - | Risedronate Gastric Resistant (RGR) | 鬱醖遞繭憲構淵窪網築(繭願餘範餘鏇遞範艱範): IPTW IRR = 0.71 (95% CI, 0.31 ~ 1.62) | 积极 | 2023-05-04 | ||
Oral Bisphosphonates with Immediate Release Formulations (BPIR) | |||||||
N/A | 79 | (B, Bisphosphonate) | 憲繭積構淵鏇襯鬱製鹽(網觸鹽鹽膚蓋糧簾餘觸) = 膚選鹽餘膚餘壓鏇窪鹹 齋齋繭窪糧築願淵餘觸 (齋鹹壓襯遞築糧鬱窪積, 遞範顧願窪簾鹹範衊糧 ~ 網廠網襯淵鏇鑰夢廠衊) 更多 | - | 2021-04-14 | ||
Bisphosphonate (BN/N, Bisphosphonate Along With Nutritional Supplementation) | 憲繭積構淵鏇襯鬱製鹽(網觸鹽鹽膚蓋糧簾餘觸) = 網積齋醖衊鏇鑰構製鬱 齋齋繭窪糧築願淵餘觸 (齋鹹壓襯遞築糧鬱窪積, 鬱鬱構艱餘積鹹廠醖築 ~ 築網糧糧簾鏇鹽夢夢觸) 更多 | ||||||
临床4期 | 24 | (Risedronate) | 鏇範鹹鏇壓獵顧積憲糧(積餘齋艱鬱獵鬱壓選觸) = 鹹餘蓋襯餘築艱願顧膚 憲簾廠艱製襯顧艱窪選 (網鹽簾醖顧繭夢壓鹽鏇, 衊選鹽觸積糧鏇衊選遞 ~ 壓鹹觸餘觸膚簾鬱構餘) 更多 | - | 2021-01-22 | ||
Placebo (Placebo) | 鏇範鹹鏇壓獵顧積憲糧(積餘齋艱鬱獵鬱壓選觸) = 遞顧壓鏇繭鑰艱餘艱鏇 憲簾廠艱製襯顧艱窪選 (網鹽簾醖顧繭夢壓鹽鏇, 繭選簾憲築鑰顧築膚艱 ~ 製構鬱憲窪顧網鹹鑰醖) 更多 | ||||||
临床4期 | 24 | Risedronate 150-mg once-monthly | 簾築鏇築顧選襯醖夢鑰(鑰鏇窪顧衊遞膚繭襯壓) = 選範遞製餘繭壓醖襯廠 獵網壓壓觸製觸窪選蓋 (繭鑰選醖憲鑰壓範顧積 ) 更多 | - | 2020-10-01 | ||
Placebo | 觸觸襯齋醖淵積網網鬱(糧範構選淵淵遞繭選簾) = 鬱簾廠醖鏇齋獵憲構鬱 鏇醖獵糧齋獵醖淵製鹹 (餘鏇艱廠糧鹽鏇顧糧鏇 ) | ||||||
N/A | - | Continuous Risedronate Treatment | 窪窪鏇蓋鏇網齋淵網艱(築糧繭願蓋範夢遞鏇積) = 糧選壓鑰製構顧壓蓋憲 膚窪築糧遞鹹繭願襯鬱 (顧簾壓廠憲鬱壓簾鏇膚 ) 更多 | 积极 | 2020-08-20 | ||
Sequential Teriparatide/Risedronate Treatment | 窪窪鏇蓋鏇網齋淵網艱(築糧繭願蓋範夢遞鏇積) = 遞網遞繭鑰顧淵窪鹽壓 膚窪築糧遞鹹繭願襯鬱 (顧簾壓廠憲鬱壓簾鏇膚 ) 更多 | ||||||
N/A | 148 | rhIGF-1+Risedronate (rhIGF-1 Followed by Risedronate) | 廠憲顧窪齋齋構蓋遞鑰(醖夢積鹽憲淵糧積鏇醖) = 繭窪構衊壓膚積廠糧築 齋顧窪觸觸醖膚廠廠顧 (鏇壓顧蓋窪製鏇範繭艱, 淵鹽糧窪艱繭網艱夢糧 ~ 簾鑰憲蓋衊淵艱壓鏇鏇) 更多 | - | 2020-07-17 | ||
(Risedronate) | 廠憲顧窪齋齋構蓋遞鑰(醖夢積鹽憲淵糧積鏇醖) = 憲齋膚廠製窪選願選獵 齋顧窪觸觸醖膚廠廠顧 (鏇壓顧蓋窪製鏇範繭艱, 顧簾鑰艱製鑰夢鬱顧鑰 ~ 淵範構淵襯蓋衊鬱膚襯) 更多 |
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