[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence pilot study of alendronate sodium tablets in Chinese healthy subjects in the fasting state

研究健康受试者空腹单次口服受试制剂阿仑膦酸钠片（海南全星制药有限公司，规格：70mg）与参比制剂阿仑膦酸钠片（商品名：福善美 ®，N.V. Organon，规格：70mg）在吸收程度和速度方面是否存在差异，评价受试制剂和参比制剂在空腹状态下给药时的生物等效性，观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To investigate whether there are differences in the extent and rate of absorption between the test preparation alendronate sodium tablets (Hainan Quanxing Pharmaceutical Co., Ltd., specification: 70 mg) and the reference preparation alendronate sodium tablets (trade name: Fosamax ®, N.V. Organon, specification: 70 mg) taken orally on an empty stomach in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date29 Sep 2024

Sponsor / Collaborator

Hainan Quanxing Pharmaceutical Co. Ltd.

100 Clinical Results associated with Alendronate Sodium

100 Translational Medicine associated with Alendronate Sodium

100 Patents (Medical) associated with Alendronate Sodium

7,308

Literatures (Medical) associated with Alendronate Sodium

01 May 2025·JOURNAL OF MOLECULAR GRAPHICS & MODELLING

In silico evaluation of bisphosphonates identifies leading candidates for SARS-CoV-2 RdRp inhibition

Article

Author: Garg, Mohit ; Vasan, Seshadri S ; Sankaranarayanan, Murugesan ; Muzaffar-Ur-Rehman, Mohammed ; Kuthe, Pranali Vijaykumar ; Chandu, Ala ; Chougule, Kishor Suryakant

The novel coronavirus disease (COVID-19) pandemic has resulted in 777 million confirmed cases and over 7 million deaths worldwide, with insufficient treatment options. Innumerable efforts are being made around the world for faster identification of therapeutic agents to treat the deadly disease. Post Acute Sequelae of SARS-CoV-2 infection or COVID-19 (PASC), also called Long COVID, is still being understood and lacks treatment options as well. A growing list of drugs are being suggested by various in silico, in vitro and ex vivo models, however currently only two treatment options are widely used: the RNA-dependent RNA polymerase (RdRp) inhibitor remdesivir, and the main protease inhibitor nirmatrelvir in combination with ritonavir. Computational drug development tools and in silico studies involving molecular docking, molecular dynamics, entropy calculations and pharmacokinetics can be useful to identify new targets to treat COVID-19 and PASC, as shown in this work and our recent paper that identified alendronate as a promising candidate. In this study, we have investigated all bisphosphonates (BPs) on the ChEMBL database which can bind competitively to nidovirus RdRp-associated nucleotidyl (NiRAN) transferase domain, and systematically down selected seven candidates (CHEMBL608526, CHEMBL196676, CHEMBL164344, CHEMBL4291724, CHEMBL4569308, CHEMBL387132, CHEMBL98211), two of which closely resemble the approved drugs minodronate and zoledronate. This work and our recent paper together provide an in silico mechanistic explanation for alendronate and zoledronate users having dramatically reduced odds of SARS-CoV-2 testing, COVID-19 diagnosis, and COVID-19-related hospitalizations, and indicate that similar observational studies in Japan with minodronate could be valuable.

11 Feb 2025·ACS Nano

Rectifying the Crosstalk between the Skeletal and Immune Systems Improves Osteoporosis Treatment by Core–Shell Nanocapsules

Article

Author: Xu, Yanhua ; Bai, Shuting ; Sun, Xun ; Ou, Yangsen ; Xiong, Kun ; He, Chunting ; He, Penghui ; Hu, Rui ; Tang, Xue ; Wei, Hongjiao ; Guo, Zhaofei ; Du, Guangsheng

Contemporary osteoporosis treatment often neglects the intricate interactions among immune cells, signaling proteins, and cytokines within the osteoporotic microenvironment. Here, we developed core-shell nanocapsules composed of a cationized lactoferrin core and an alendronate polymer shell. By tuning the size of these nanocapsules and leveraging the alendronate shell, we enabled precise delivery of small interfering RNA targeting the Semaphorin 4D gene (siSema4D) to specific bone sites. This strategy integrates the antiresorptive drug alendronate with siSema4D, efficiently inhibiting osteoclast (OC) differentiation and bone resorption, while promoting osteogenesis to restore the balance between osteoblasts (OBs) and OCs. Moreover, encapsulating siSema4D within the nanocapsules helps to mitigate immunological cascades, thereby reversing the inflammatory microenvironment and restoring immune homeostasis and providing insights into the immunomodulatory effects of Sema4D in osteoporosis therapy. In both ovariectomized and senile osteoporotic mouse models, local intramuscular administration of core-shell nanocapsules effectively rectified the imbalance between the skeletal and immune systems, significantly enhancing the overall efficacy of osteoporosis treatment. Our findings underscore the therapeutic promise of addressing the multifaceted osteoporotic microenvironment through targeted interventions.

02 Feb 2025·JOURNAL OF BONE AND MINERAL RESEARCH

Romosozumab improves microarchitecture as assessed by tissue thickness–adjusted trabecular bone score in postmenopausal women with osteoporosis

Article

Author: Betah, Donald ; McClung, Michael R ; Oates, Mary ; Wang, Zhenxun ; Leder, Benjamin Z ; Kendler, David L ; Timoshanko, Jen

Abstract:

Bone mineral density (BMD) is only one of several bone strength determinants affected by osteoporosis therapies. Trabecular Bone Score (TBS), a gray-level texture index determined from lumbar spine (LS) dual-X-ray absorptiometry scans, is an indirect measure of bone microarchitecture independent of and complementary to BMD and clinical risk factors. In the Active-Controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk (ARCH), monthly subcutaneous romosozumab 210 mg for 12 mo followed by 24-mo open-label weekly oral alendronate 70 mg (romosozumab-to-alendronate) significantly reduced fracture risk compared to 36-mo alendronate alone in postmenopausal women with osteoporosis and prior fracture. This analysis evaluated tissue thickness–adjusted TBS (TBSTT) in a subgroup of patients from ARCH who had post-hoc TBS measurements at baseline and at least one post-baseline visit at months 12, 24, and 36. Baseline characteristics were similar between romosozumab-to-alendronate (n = 190) and alendronate alone (n = 188). Romosozumab led to significantly greater gains in TBSTT vs alendronate at month 12 (least squares mean difference, 3.6%), with greater gains maintained after transition to alendronate and persisting at months 24 (2.9%) and 36 (2.3%; all p<.001). Romosozumab-to-alendronate increased the percentage of individual patients with “normal” TBSTT from 28.9% at baseline to 48.1%, 43.9%, and 45.4% at months 12, 24, and 36, respectively, and decreased the percentage of individual patients with degraded TBSTT from 52.6% to 33.3%, 36.0%, and 33.5%, respectively (all p<.001). A similar but smaller trend was observed with alendronate alone from baseline through month 36 (p ≤.012). Changes in TBSTT and LS BMD were largely unrelated from baseline to month 12 (romosozumab-to-alendronate, r2 = 0.065; alendronate alone, r2 = 0.021) and month 36 (r2 = 0.058; r2 = 0.057, respectively). In postmenopausal women with osteoporosis and prior fracture, 12-mo romosozumab followed by 24-mo alendronate significantly improved bone microarchitecture estimated by TBSTT more than 36-mo alendronate alone.

News (Medical) associated with Alendronate Sodium

02 Jan 2025

·www.accesswire.com

Radius Pharmaceuticals Announces Licensing Agreement with Pharmanovia to Register and Commercialize Abaloparatide in China and Select Asia Pacific Territories

BOSTON, MA / ACCESSWIRE / January 2, 2025 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. (\"Radius\" or the \"Company\"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Pharmanovia the exclusive commercialization rights to abaloparatide, a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. The licensing agreement covers markets in the Asia Pacific region, specifically China, Singapore, Thailand, Indonesia, Vietnam, Taiwan, Hong Kong, Malaysia, Macau and the Philippines. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.\"We are very pleased to enter into a partnership with Pharmanovia with the goal of making abaloparatide available to patients in additional global markets,\" said Scott Briggs, Chief Executive Officer of Radius. \"This collaboration partners two companies that share a commitment to improving the lives of patients with osteoporosis. With Pharmanovia\'s expertise in osteoporosis and their proven track record of success in these territories, we can look forward to significantly expanding abaloparatide access to patients in need of osteoporosis treatment options.\"\"We are thrilled to expand our portfolio and bring to the Asia Pacific region such an important and innovative osteoporosis treatment,\" said James Burt, Chief Executive Officer of Pharmanovia. \"This deal recognizes the strength of our commercial model in APAC, and China in particular, where we have one of the leading osteoporosis commercial platforms.\"Under the terms of the Licensing Agreement, Radius would be eligible to receive an upfront payment as well as regulatory and commercial milestones plus tiered royalties on net sales.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius\' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company\'s presence in bone health.About Pharmanovia:Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by rediscovering, repurposing or re-engineering established medicines or by bringing to market novel medicines to improve patient outcomes and experiences. With a diverse and growing team in over 160 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas - Endocrinology, Neurology, Cardiovascular and Oncology both in rare and established diseases or conditions.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]SOURCE: Radius Health Related Documents:

Drug ApprovalLicense out/in

09 Dec 2024

·www.accesswire.com

Radius Pharmaceuticals Expands Abaloparatide Licensing Agreement with Theramex Granting Additional Commercialization Rights Including Mexico, Canada, South Africa, Israel, and Russia

BOSTON, MA / ACCESSWIRE / December 9, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Theramex the exclusive commercialization rights to ELADYNOS® (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, for Mexico, Canada, Israel, South Africa, and Russia. Theramex will also have the opportunity to commercialize ELADYNOS® in other agreed upon unpartnered regions. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.Under the License Agreement, Radius will receive an upfront and milestone payment plus tiered royalties."Theramex has been an excellent collaborative partner, and we are very pleased to expand our abaloparatide partnership to include additional important global markets," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to making abaloparatide accessible to patients, and the expansion of our existing partnership helps provide access to additional patients in need of osteoporosis treatment options.""Following the launch of abaloparatide in Europe, we are excited to bring this innovative product to more patients globally and drive further growth through our direct markets and our commercial partnerships. This agreement expands our successful relationship with Radius, and we look forward to continuing our close collaboration," said Rob Stewart, Chief Executive Officer of Theramex.In addition to these new territories, Theramex will continue to commercialize and distribute ELADYNOS® on an exclusive basis in the European Economic Area, the United Kingdom, Australia, and Brazil. ELADYNOS® received approval in the European Economic Area in December 2022 and Australia in November 2024 and has been launched in select countries.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health.About Theramex:Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering osteoporosis, contraception, fertility, menopause and uterine health. Theramex's commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]Edward Rees: Chief Corporate Development Officer, TheramexEmail: to [email protected]SOURCE: Radius Health

Drug ApprovalLicense out/in

25 Jun 2024

·www.biospace.com

Radius Pharmaceuticals Announces the Appointment of Renata Sklodowska, M.D. as Senior Vice President of Medical Operations

BOSTON, MA / ACCESSWIRE / June 25, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced the appointment of Renata Sklodowska, M.D. as Senior Vice President, Medical Operations. Dr. Sklodowska joins Radius with over fifteen years of clinical development, regulatory, and medical affairs experience. She will report to Scott Briggs, Chief Executive Officer, and will oversee Medical Operations including Medical Affairs, Regulatory Affairs, and Pharmacovigilance (PV). "I am very pleased to welcome Renata to our Executive Leadership Team at Radius," said Scott. "Renata's extensive pharmaceutical industry experience, as well as her strong leadership track record in global medical and scientific affairs, will be extremely valuable as Radius continues to build its presence in bone health and related areas. Of particular importance will be Renata's strong patient-focus and ability to build alliances with medical, scientific, and patient communities to support our efforts with TYMLOS® and BINOSTO®." Dr. Sklodowska is an accomplished international pharmaceutical and biotech executive with Medical and Scientific Affairs expertise,as well as commercial experience. Her tenure includes more than fifteen years in the rare diseases area, including Endocrinology, with proven success preparing and supporting successful product launches as well as managing product portfolios. Dr. Sklodowska has an established history leading Medical Affairs activities for development stage and marketed drugs and a tested ability to create, train, and lead cross-functional teams to attain business objectives. Dr. Sklodowska has established global PV systems and provided oversight for the PV, drug safety, and risk management activities for numerous marketed products. As part of her responsibilities, she will also provide important scientific and medical expertise and guidance to support therapeutic area and product assessments behind business development efforts at Radius. "I look forward to joining the Radius team and applying my years of experience to build upon the company's successes to date, and to not only support TYMLOS® and BINOSTO®, but to also provide medical and strategic insight to explore opportunities to expand the Radius portfolio over time," stated Dr. Sklodowska. Prior to joining Radius, Dr. Sklodowska held several leadership positions in clinical development and medical affairs at biotech and global pharmaceutical companies, having most recently served as Vice President of Medical Affairs at F2G and Recordati Rare Diseases. Dr. Sklodowska received her Doctor of Medicine degree from the Medical University of Bialystok, Poland where she was also an attending physician. About Radius: Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also recently announced an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health. Contact: Sara Goldberg: Head of Communications Email: corporatecommunications@radiuspharm.com Phone: +1 (631) 379-8374 SOURCE: Radius Health, Inc. View the original press release on accesswire.com

Executive ChangeLicense out/inDrug Approval

100 Deals associated with Alendronate Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00939	Alendronate Sodium	M05BA04	DBSALT000315

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Fractures, Bone	US	Merck & Co., Inc.	17 Sep 2003
Osteoporotic Fractures	US	Merck & Co., Inc.	17 Sep 2003
Glucocorticoid-induced osteoporosis	US	Organon & Co.	16 Jun 1999
Osteitis Deformans	US	Organon & Co.	29 Sep 1995
Osteoporosis, Postmenopausal	US	Organon & Co.	29 Sep 1995
Osteoporosis	IT	Merck Sharp & Dohme Corp.	01 Jan 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-metastatic prostate cancer	Phase 3	-	Merck Frosst Canada Ltd.	01 Jul 2005
Hip Fractures	Phase 3	CA	Merck Frosst Canada Ltd.	01 Jan 2003
Diabetes Mellitus	Phase 2	IL	Biorest Ltd.	01 Apr 2016
Juvenile Osteoporosis	Phase 2	US	Merck Sharp & Dohme Corp.	01 Sep 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05387200 (Pubmed \| Arch Osteoporos)	Phase 4	Osteoporosis, Postmenopausal	170	Alendronate solution (ALN-S)	zhzjgbhgox(xboirqxhoe) = dlnmwnxngo skiiecioji (dbhrjdjoiv, 0.6) View more	Positive	26 Nov 2024
NCT05387200 (Pubmed \| Arch Osteoporos)	Phase 4	Osteoporosis, Postmenopausal	170	Alendronate tablet (ALN-T)	zhzjgbhgox(xboirqxhoe) = dircurapfi skiiecioji (dbhrjdjoiv, 0.6) View more	Positive	26 Nov 2024
EULAR2024	Not Applicable	Osteoporosis	57	Alendronate	kanrxtbmxy(mlgyfgssha) = There were no cases of significant adverse effects specifically atypical femur fractures or osteonecrosis of jaw ptrbummfst (etesuwvocr )	-	05 Jun 2024
ENDO2024	Not Applicable	Female Genital Neoplasms	-	Denosumab users	wzuieycwge(lxhifeatwu) = efiyvzzxzj bllszudxki (fonvukleco, -0.12% - 0.26%)	Positive	01 Jun 2024
ENDO2024	Not Applicable	Female Genital Neoplasms	-	Denosumab users	ppvzozwbmi(wfkkzgsqii) = ycxliccpic srwwgntjgc (rxfotnltfe, -0.12% - 0.26%)	Positive	01 Jun 2024
ENDO2024	Not Applicable	Osteosclerosis	35	Alendronate	rpcaduhkaz(csmuytetxb) = lbbqjhqpyw ndbhohwwos (tpjkhfpwdn )	Negative	01 Jun 2024
ENDO2024	Not Applicable	Osteosclerosis	35	Zoledronic Acid	rpcaduhkaz(csmuytetxb) = hdhphycabq ndbhohwwos (tpjkhfpwdn )	Negative	01 Jun 2024
NCT03396315 (CTgov)	Phase 2	Juvenile Osteoporosis	24	Alendronate (Alendronate)	jewskaswot(fndrdphhqk) = dwldvhhtqz ywkczrgppm (qaudalplgh, yjslkdqfoc - gpestumhiz) View more	-	08 May 2024
NCT03396315 (CTgov)	Phase 2	Juvenile Osteoporosis	24	Zoledronic Acid (Zoledronic Acid)	jewskaswot(fndrdphhqk) = tflcjkkyrg ywkczrgppm (qaudalplgh, zvzkdokymz - dizdxskysl) View more	-	08 May 2024
WCO_IOF_ESCEO2024	Not Applicable	Osteoporosis cathepsin K \| phosphorus \| 25 HO vitamin D ... View more	28	Alendronate (Postmenopausal women with osteoporosis)	pplkrbsmew(bnolcbikcs) = zudzpvdspw azcedpzazy (xzenrisdjo )	-	11 Apr 2024
WCO_IOF_ESCEO2024	Not Applicable	Osteoporosis bone turnover markers	-	Alendronate	wvwpusyaxq(weoirooqub) = eyovpwwxlb dfsozmueve (jawnwktolo ) View more	-	11 Apr 2024
NCT01460654 (CTgov)	Phase 2	Hypogonadism \| Osteoporosis	44	Testosterone+Placebo Alendronate (Testosterone and Placebo Alendronate)	vihwvamkrc(tsfzlglxif) = dankmpufzq easbwnwhji (ouqufdqtzq, abazudoeuh - eplhnuvubb) View more	-	12 Oct 2023
NCT01460654 (CTgov)	Phase 2	Hypogonadism \| Osteoporosis	44	Alendronate+Placebo Testosterone (Alendronate and Placebo Testosterone)	vihwvamkrc(tsfzlglxif) = xafwalaopp easbwnwhji (ouqufdqtzq, vcxvlntdkn - dwwapcyhrf) View more	-	12 Oct 2023
WCO_IOF_ESCEO2023	Not Applicable	-	-	Alendronate	gluodtywsp(tlfrktitzv) = dnzrbgkgff msihzifiml (qloigucdne )	-	04 May 2023

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