阿仑膦酸钠/胆骨化醇(Alendronate Sodium/Cholecalciferol) - 药物靶点：VDR_在研适应症：骨质疏松症，绝经期后骨质疏松_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Adrovance、Alendronate Sodium Trihydrate/Colecalciferol、Alendronate Sodium/Colecalciferol

+ [10]

靶点

VDR

作用机制

VDR激动剂(维生素D受体激动剂)、破骨细胞抑制剂

治疗领域

内分泌与代谢疾病皮肤和肌肉骨骼疾病

在研适应症

骨质疏松症绝经期后骨质疏松

非在研适应症

维生素D缺乏症

原研机构

Merck Sharp & Dohme Corp.

在研机构

Organon NV

Organon & Co.Merck Sharp & Dohme Farmaceutica Ltda.

+ [1]

非在研机构

Merck Sharp & Dohme Corp.

最高研发阶段批准上市

首次获批日期

美国 (2005-04-07),

绝经期后骨质疏松骨质疏松症

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C31H63NNaO11P2

InChIKeyZBOIUMYEYAMMKJ-FYLNQELCSA-N

CAS号871265-92-8

关联

14

项与阿仑膦酸钠/胆骨化醇相关的临床试验

CTR20241313 / Active, not recruiting临床1期

阿仑膦酸钠维D3片（Ⅱ）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

按有关药代动力学试验的规定，选择杭州默沙东制药有限公司为生产商的阿仑膦酸钠维D3片（Ⅱ）（商品名：福美加®；规格：每片含阿仑膦酸钠70mg（以阿仑膦酸计）与维生素D3 5600IU（相当于140μg））为参比制剂，对南京九霄药业有限公司持有的受试制剂阿仑膦酸钠维D3片（Ⅱ）（规格：每片含阿仑膦酸钠70mg（以阿仑膦酸计）与维生素D3 5600IU（相当于140μg））进行空腹口服生物等效性试验，比较两种制剂在中国健康志愿者体内的血药浓度经时过程，估算相应的药代动力学参数。同时观察健康受试者口服受试制剂和参比制剂后的安全性。

开始日期2024-05-28

申办/合作机构

南京九霄药业有限公司

EUCTR2019-003101-97-ES / Unknown status临床4期IIT

An unicentric, open, randomized and crossover clinical trial to evaluate vitamin D supplementation effect of colecalciferol versus calcidiol in mineral metabolism in hemodialisis patients.

开始日期2020-02-18

申办/合作机构-

NCT02132026 / Completed临床2期IIT

SALTIRE II: Bisphosphonates and RANKL Inhibition in Aortic Stenosis

Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure and sudden death. It is the commonest valve disease requiring surgery in the developed world and as the population becomes increasingly older, it is predicted that the prevalence of aortic stenosis will double in the next 20 years. Currently the only treatment is replacement of the aortic valve. Whilst this is excellent treatment, not everyone is suitable for it.
The primary objective of our study is to determine whether 2 drugs used in the treatment of osteoporosis (a condition of bone thinning) can halt/retard the progression of aortic stenosis. This is on the basis that studies have suggested that altered regulation of calcium metabolism may be an important mechanism perpetuating the disease. Both drugs work by reducing calcium release into the bloodstream from bones and therefore calcification of the aortic valve.
150 patients will therefore be randomly allocated to either of the trial drugs which are denosumab,the bisphosphonate (alendronic acid), or a placebo.
Positron Emission Tomography (PET) scanning is a technique where biochemically active molecules are injected and are taken up at sites of ongoing calcification activity where they emit radiation and can be detected by the PET scanner. We have previously shown that this technique can demonstrate areas of newly developing calcification on an aortic valve.
We therefore propose that patients receiving bisphosphonates or denosumab will have reduced evidence of active calcification and slower progression of their disease at two years as assessed by Echocardiography (ultrasound) and a change in their calcium score (quantity of calcium on the aortic valve measured using Computed Tomography [CT] ).
The data from this study will then be used to design a larger trial.

开始日期2014-11-12

申办/合作机构

The University of Edinburgh

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100 项与阿仑膦酸钠/胆骨化醇相关的临床结果

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100 项与阿仑膦酸钠/胆骨化醇相关的转化医学

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100 项与阿仑膦酸钠/胆骨化醇相关的专利（医药）

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4

项与阿仑膦酸钠/胆骨化醇相关的文献（医药）

2008-03-01·Current medical research and opinion4区 · 医学

Cost-effectiveness of a fixed dose combination of alendronate and cholecalciferol in the treatment and prevention of osteoporosis in the United Kingdom and The Netherlands

4区 · 医学

Article

作者: Jansen, Jeroen P. ; Bergman, Gert ; Sen, Shuvayu S. ; Gaugris, Sabine

OBJECTIVE:

To evaluate the cost-effectiveness of a fixed dose combination of alendronate 70 mg and cholecalciferol 2800 IU (alendronate/vitamin D3; Fosavance) versus no treatment, alendronate with dietary vitamin D supplements and ibandronate in the treatment of osteoporosis in the UK and Netherlands.

METHODS:

A patient simulation model was developed. One-year cycles included health states related to hip, vertebral, wrist and proximal humerus fractures, as well as death due to hip fractures and other causes. Effect of treatment was extracted from alendronate and ibandronate clinical trials. Direct costs and utilities were derived from other literature. Analyses were performed for women with a history of vertebral fractures and osteoporosis aged 50, 60, 70 and 80 years. Probabilistic sensitivity analyses were undertaken to estimate the uncertainty of outcomes.

RESULTS:

In the UK, alendronate/vitamin D3 was cost-effective compared to no treatment in women 70 years and older with osteoporosis ( pound17 439 per quality-adjusted life year [QALY] gained) and women 60 years and older with a history of vertebral fractures ( pound29 283 per QALY gained). For women 80 years of age alendronate/vitamin D3 was cost-saving combined with QALY gains. Alendronate/vitamin D3 was cost-saving relative to alendronate with dietary supplements. Relative to ibandronate, alendronate/vitamin D3 was cost-effective in women 50 years ( pound19 095 per QALY gained) and economically dominant in women 60 years or older. Comparable results were observed for the Netherlands.

CONCLUSIONS:

Given the underlying assumptions and data used, this economic modelling study showed that alendronate/vitamin D3 is cost-effective in women 70 years or older with osteoporosis and in women 60 years or older with a history of vertebral fractures in the UK and Netherlands. Alendronate/vitamin D3 is economically dominant over ibandronate in women with a history of vertebral fractures aged 60 and over and cost-saving relative to alendronate with dietary supplements.

2007-01-17·Revue medicale suisse

[Osteoporosis treatment].

Review

作者: Uebelhart, Brigitte ; Rizzoli, René

The diagnosis threshold of osteoporosis is based on low bone density value. The therapeutic threshold is modulated by clinical risk factors. Denosumad, an antibody raised against RANK-Ligand, is a potent bone resorption inhibitor. Efficacy on the reduction of fracture incidence is well documented with 800 IU of vitamin D and 1 g of calcium per day. Tibolone (Livial) prevents vertebral fractures but increases strokes. Strontium ranelate (Protélos) prevents fractures over 5 years duration even in women older than 80. Native parathormone (84AA) (Préotac), reduces vertebral fractures. Alendronate (Fosavance), monthly oral and trimonthly i.v. Ibandronate (Bonviva) are the new possibilities of treatment with bisphosphonates. Yearly i.v. zoledronate injections prevent any kind of osteoporotic fractures.

2007-01-01·Reumatizam

[Alendronate and vitamin D (Fosavance): persistence, adherence and importance of vitamin D].

Review

作者: Grazio, Simeon ; Morović-Vergles, Jadranka

Persistence and adherence are major determinants of optimal results in the treatment of osteoporosis. In order to improve the efficacy of antiresorptive drugs, fewer demands on patients and better adherence were obtained with less frequent dosing schedule. Once-weekly and once-monthly oral bisphophonates showed equivalency with once daily medications. Comparison of persistence and adherence between weekly and monthly bisphosphonate regimens revealed conflicting results. In Croatia, persistence and adherence of weekly alendronate seem to be better than in other countries. In the light of compliance problems there is a need to assure adequate intake of vitamin D, because it is essential for prevention and treatment of osteoporosis and osteoporotic fractures. Vitamin D has other beneficial effects, particularly on neuromuscular performances. A high prevalence of vitamin D inadequacy was seen across all geographic regions. Weekly alendronate and vitamin D in one tablet provides proven fracture prevention at the spine and hip, and assure that patients receive a weekly dose of vitamin D.

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项与阿仑膦酸钠/胆骨化醇相关的新闻（医药）

2024-08-15

·PMLiVE

NICE recommends Theramex’s Eladynos to treat bone disease after menopause

The National Institute for Health Care and Research has recommended Theramex’s Eladynos (abaloparatide) as an option for treating bone disease after menopause. Available on the NHS in England in three months, the drug is set to benefit more than 14,000 people in the UK who are seeking treatment for osteoporosis after menopause, if there is a very high risk of fracture. Osteoporosis, a bone disease that affects 3.8 million people in the UK, develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and bone density reduces, making broken bones more common. Other treatments for the disease include bisphosphonates such as alendronic acid and ibandronic acid, Eli Lilly’s selective oestrogen receptor modulator, Evista (raloxifene), parathyroid hormone treatments including teriparatide, and biological medicines including Amgen’s Prolia (denosumab) and Amgen/UCB’s Evenity (romosozumab). NICE’s decision was based on patients descriptions of how debilitating osteoporosis can be and how it all impacts day-to-day life, impairing mental and physical health. Theramex’s Eladynos is designed to increase bone density by stimulating the cells that produce new bone while also reducing the risk of fracture, providing an alternative for patients who have not responded to or cannot tolerate usual treatment options. Proven to be more clinically and cost-effective, the alternative treatment option comes as a pre-filled pen that is injected into the muscle through the skin. Prior to this, in March, Bayer shared positive long-term results from the late-stage OASIS 3 study, which supported the use of its investigational non-hormonal menopause drug, elinzanetant, to treat moderate-to-severe vasomotor symptoms (VMS), such as hot flashes, which are reported by up to 80% of women during the menopausal transition. In April, a Canadian study published in Neurology revealed that early menopause and a higher risk of cardiovascular disease could be linked to cognitive decline later in life.

临床结果临床3期上市批准

100 项与阿仑膦酸钠/胆骨化醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M05BB03	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
骨质疏松症	美国	Organon & Co.	2005-04-07
绝经期后骨质疏松	美国	Organon & Co.	2005-04-07

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
维生素D缺乏症	临床3期	-	Merck Sharp & Dohme Corp.	2004-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASN2021	N/A	小管间质性肾炎和葡萄膜炎	-	Alendronic Acid	遞餘艱齋廠獵遞鬱壓餘(膚選築積願窪淵齋襯願) = recurrence of her ocular involvement and was diagnosed with anterior uveitis by ophthalmology 衊範鬱鹹獵廠糧壓淵觸 (夢淵鑰襯糧襯蓋鹹糧顧 ) 更多	积极	2021-10-27
				Prednisone
NCT00803790 (CTgov)	临床1期	骨质疏松症	318	Alendronate+Vitamin D (Alendronate+Vitamin D Combo)	衊觸觸艱衊願鹹壓鑰積(壓網夢艱範鬱壓觸齋齋) = 齋壓鏇餘蓋鑰膚淵艱襯襯積鑰餘範醖繭積製鑰 (餘淵膚窪鏇範襯觸網製, 範遞構鹹積醖壓夢鏇觸 ~ 膚壓積憲築廠襯壓壓範) 更多	-	2011-05-09
				Alendronate (Alendronate)	衊觸觸艱衊願鹹壓鑰積(壓網夢艱範鬱壓觸齋齋) = 獵壓觸衊遞鬱餘範鑰醖襯積鑰餘範醖繭積製鑰 (餘淵膚窪鏇範襯觸網製, 選範鬱積築衊鬱願繭鬱 ~ 網繭觸廠壓鹽繭窪膚蓋) 更多
NCT00729651 (0217A-263, CTgov)	临床4期	绝经期后骨质疏松	343	Fosamax (Fosamax Plus D)	製簾鑰築鬱夢築網遞獵(淵糧襯構製鹽範鏇獵積) = 願膚選築醖鏇選壓齋襯衊簾鏇蓋壓選積壓鏇顧 (製糧製壓夢積顧遞網顧, 憲鬱艱鑰遞顧構構鑰膚 ~ 簾鏇鑰齋鹹鏇願築範範) 更多	-	2010-04-02
				Fosamax (Fosamax)	製簾鑰築鬱夢築網遞獵(淵糧襯構製鹽範鏇獵積) = 餘網窪鹽壓膚鹽糧淵範衊簾鏇蓋壓選積壓鏇顧 (製糧製壓夢積顧遞網顧, 願鬱鑰衊醖齋鹹鏇製範 ~ 選簾淵製願範鹹選願鏇) 更多
NCT00806416 (CTgov)	临床1期	骨质疏松症	244	Alendronate+Vitamin D (Alendronate/Vitamin D Combination)	鹽築壓壓築鹹鹹壓鹹顧(遞鬱壓鏇簾餘鬱鹹簾窪) = 齋築鹽壓齋壓壓範鑰淵簾艱範鏇鏇齋鏇淵糧淵 (網鏇鹽鹹網壓夢鏇鹽獵, 窪遞繭構淵襯選鬱鬱遞 ~ 願膚餘廠鏇鑰醖壓鑰餘) 更多	-	2010-02-12
				Alendronate (Alendronate)	鹽築壓壓築鹹鹹壓鹹顧(遞鬱壓鏇簾餘鬱鹹簾窪) = 鏇積鑰鬱窪窪遞廠獵遞簾艱範鏇鏇齋鏇淵糧淵 (網鏇鹽鹹網壓夢鏇鹽獵, 網夢獵鏇選製鹹鏇廠網 ~ 構範齋遞鏇鹽鏇廠觸獵) 更多