[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.

CTRI/2024/07/071279

/ Not yet recruitingPhase 2/3IIT

Comparative Evaluation of Clinical Efficacy of Topical 1% Sodium Alendronate gel as an adjunct to open flap debridement with laser biostimulation in the treatment of chronic periodontitis : A Split Mouth Randomized Controlled Clinical Trial. - NIL

Start Date30 Jul 2024

Sponsor / Collaborator-

100 Clinical Results associated with Alendronate Sodium

100 Translational Medicine associated with Alendronate Sodium

100 Patents (Medical) associated with Alendronate Sodium

5,445

Literatures (Medical) associated with Alendronate Sodium

01 Feb 2025·Biomaterials advances

Carboxymethyl chitosan/alendronate sodium/Sr2+ modified TiO2 nanotube arrays enhancing osteogenic activity and antibacterial property

Article

Author: Liu, Tingting ; Ji, Yan ; Jia, Kunpeng ; Ma, Wenfu ; Zuo, Changpeng ; Chen, Jie ; Wang, Lingtao ; Pan, Changjiang ; Xu, Yan ; Zhang, Qiuyang

Titanium and its alloys are widely used as orthopedic implants owing to their good mechanical properties and excellent corrosion resistance. However, the insufficient osteogenic activity and antibacterial properties hinder their clinical applications. To address these issues, TiO₂ nanotube arrays (TNT) were first fabricated on the TA2 alloy surface via an anodizing technique, and strontium ions (Sr²⁺) were then loaded by hydrothermal reaction (TNT + Sr) and annealing treatment (TNT + A). Subsequently, the polydopamine layer (TNT + PDA) was constructed to immobilize the carboxymethyl chitosan and alendronate sodium (TNT + CA) mixture. The prepared coatings were thoroughly characterized by scanning electron microscopy (SEM), energy dispersive spectrometer (EDS), X-ray photoelectron spectrometer (XPS), attenuated total reflection-Fourier transform infrared spectroscopy (ATR-FTIR), X-ray diffractometer (XRD), and water contact angle measurement. The results confirmed that Sr²⁺ ions, polydopamine, and carboxymethyl chitosan/alendronate sodium were successfully immobilized on the nanotubes. The coating of TNT + CA significantly enhanced the hydrophilicity, and effectively delayed the release of Sr²⁺ and alendronate. The TNT + CA coating significantly promoted osteoblast adhesion and proliferation, and up-regulated the expressions of alkaline phosphatase (ALP), osteocalcin (OCN), and osteoblast-specific transcription factor (RUNX2). TNT + CA was able to rapidly induce in situ hydroxyapatite deposition from the simulated body fluid (SBF). Moreover, TNT + CA coating showed inhibition against Escherichia coli and Staphylococcus aureus (especially against Escherichia coli). The prepared TNT + CA coating provides a novel strategy for enhancing bone affinity, improving osteoblast behaviors, and antibacterial properties of titanium-based biomaterials.

01 Jan 2025·Biomaterials advances

Bone-targeted ultrasound-responsive nanobubbles for siRNA delivery to treat osteoporosis in mice

Article

Author: Razavi, Mehdi ; Pattilachan, Tara ; Hartmann, Thomas ; Flores, Abel Córdova ; Sotoudehbagha, Pedram

This project aimed to study the efficacy of a bone-targeted ultrasound-responsive nanobubble (NB) platform to deliver gene-silencing cathepsin K (CTSK) siRNA into the bone for osteoporosis treatment using in vitro and in vivo studies. To this end, characterization of CTSK siRNA loaded NB functionalized with alendronate (NB-CTSK siRNA-AL) was performed using transmission electron microscopy (TEM) imaging, and a release profile was obtained through fluorescent spectroscopy. In vitro studies were conducted by culturing NB-CTSK siRNA-AL with osteoclasts to evaluate siRNA uptake, CTSK expression, and the expression of tartrate-resistant acid phosphatase (TRAP). A control group and an NB-CTSK siRNA-AL treated group of ovariectomized (OVX) mice (n = 4) were tested. The OVX group that received treatment underwent weekly sessions for 4 weeks, during which they were exposed to low-intensity pulsed ultrasound (LIPUS) stimulation following administration of NB-CTSK siRNA-AL, prior to being sacrificed. Both groups underwent a series of tests to evaluate the bone targeting, safety, and efficacy of the nanoplatform. These tests included biodistribution studies conducted at 4 h and 24 h post-injection, a 3-point bending test of the femurs, nano-computed tomography analysis, as well as Hematoxylin & Eosin histological staining, Masson's Trichrome staining, and CTSK staining. The biodistribution showed the accumulation of NB-CTSK siRNA-AL in the bone and liver. Results showed that the OVX mice treated with NB-CTSK siRNA-AL had increased distal cortical bone thickness (174.4 ± 5.28 μm vs. 144.3 ± 10.66 μm, p > 0.05)) and bone volume fraction (16.5 ± 3.96 % vs. 6.55 ± 0.13 % (p > 0.05)). A reduced collagen degradation and downregulated CTSK expression were evident in the staining procedures. No adverse effects were recorded within histological assessments on the liver, kidney, and heart post-treatment. Morphology was shown to be normal and healthy within muscle cells post-LIPUS stimulation of NB-CTSK siRNA-AL. From these results, it can be concluded that an ultrasound-mediated NB-CTSK siRNA-AL can serve as a reliable, safe CTSK siRNA carrier to bone-specific targets for in vivo osteoporosis treatment.

01 Jan 2025·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

Inhibition of osteocyte apoptosis does not prevent iron overload-induced bone resorption and bone loss

Article

Author: Yang, Jiancheng ; Zhang, Junde ; Wu, Jiawen ; Zhang, Yandong ; Zhou, Jianhua ; Yang, Linbo ; Wang, Shenghang ; Hu, Yawei ; Guo, Zengfeng

Iron overload leads to apoptosis and increased expression of receptor activator of nuclear factor kappa-Β ligand (RANKL) in osteocytes, which in turn accelerates osteoclastogenesis. Since osteocytes are the main RANKL producers, we hypothesized that apoptotic osteocytes increase RANKL expression in osteocytes, which in turn stimulates osteoclastogenesis and bone resorption. In this study, alendronate or IG9402, a bisphosphonate (BP) analog which does not inhibit bone resorption, inhibited iron overload-induced osteocyte apoptosis and increased RANKL expression. Both BPs also prevented osteoblast apoptosis but did not inhibit the increase in osteoblastic RANKL. Alendronate, but not IG9402, prevented the increase in osteoclastogenesis and serum levels of the bone resorption marker C-telopeptide of type I collagen (CTX) in iron-overloaded mice. Alendronate also prevented the iron overload-induced reduction in femoral bone mineral density, disruption of bone microstructure, and weakness of bone strength. Although IG9402 did not prevent bone loss due to iron overload, it partially prevented reduction of strength, suggesting that osteocyte viability contributes to the maintenance of bone strength. In conclusion, although osteocyte apoptosis in the presence of iron overload leads to an increase in osteocytic RANKL production. However, blocking these events was not sufficient to inhibit iron overload-induced osteoclastogenesis and bone loss.

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.

to view more data

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
Coronary Stenosis	Phase 2	IL	Biorest Ltd.	01 Sep 2008
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)	lnspgcniwn(pmjpudwanl) = qgjdpsvvhl qmvmuzgutv (zqbjuhxtjh, 0.6) View more	Positive	26 Nov 2024
NCT05387200 (Pubmed \| Arch Osteoporos)	Phase 4	Osteoporosis, Postmenopausal	170	Alendronate tablet (ALN-T)	lnspgcniwn(pmjpudwanl) = uabklkmosh qmvmuzgutv (zqbjuhxtjh, 0.6) View more	Positive	26 Nov 2024
EULAR2024	Not Applicable	Osteoporosis	57	Alendronate	glnsejvfut(phcemrjnhi) = There were no cases of significant adverse effects specifically atypical femur fractures or osteonecrosis of jaw bkwtecccng (gsyeiycuia )	-	05 Jun 2024
ENDO2024	Not Applicable	Female Genital Neoplasms	-	Denosumab users	qnchbjpini(snqsgxorfv) = heemiusnbx alcijvtdsr (llakcfqjhr, -0.12% - 0.26%)	Positive	01 Jun 2024
ENDO2024	Not Applicable	Female Genital Neoplasms	-	Denosumab users	hdkdzcjgkw(rlidpwvhxr) = nduqanufbg ehnaviblpf (obozknskdl, -0.12% - 0.26%)	Positive	01 Jun 2024
ENDO2024	Not Applicable	Osteosclerosis	35	Alendronate	lgwnmlddth(dbrrvgkyio) = ytgxutlfng cuwoqhxdgt (hgaqipofwl )	Negative	01 Jun 2024
ENDO2024	Not Applicable	Osteosclerosis	35	Zoledronic Acid	lgwnmlddth(dbrrvgkyio) = temyqiipfz cuwoqhxdgt (hgaqipofwl )	Negative	01 Jun 2024
NCT03396315 (CTgov)	Phase 2	Juvenile Osteoporosis	24	Alendronate (Alendronate)	ccmcgbnjzj(ulashoqrgk) = togxdvmkqf ycvvibtgjn (ufeajkaarx, goqwsorpkp - gjdltuvepn) View more	-	08 May 2024
NCT03396315 (CTgov)	Phase 2	Juvenile Osteoporosis	24	Zoledronic Acid (Zoledronic Acid)	ccmcgbnjzj(ulashoqrgk) = qwkxjmprrd ycvvibtgjn (ufeajkaarx, pumohpniuh - ukzxiwuswv) View more	-	08 May 2024
WCO_IOF_ESCEO2024	Not Applicable	Osteoporosis bone turnover markers	-	Alendronate	nmlnoqxkkv(ikytcylypn) = ermsirwyau inocorrhnj (ubnbpsborc ) View more	-	11 Apr 2024
WCO_IOF_ESCEO2024	Not Applicable	Osteoporosis cathepsin K \| phosphorus \| 25 HO vitamin D ... View more	28	Alendronate (Postmenopausal women with osteoporosis)	ocvtxruari(dyrbyvxjwf) = elxfjbxhre jfbucosthf (lkdqbudzjq )	-	11 Apr 2024
NCT01460654 (CTgov)	Phase 2	Hypogonadism \| Osteoporosis	44	Testosterone+Placebo Alendronate (Testosterone and Placebo Alendronate)	frvspybjkz(kiemvjlqvi) = hmzosjpcwv enjlghajwv (oglctfruks, zaqcbikfdk - ucdvrufsls) View more	-	12 Oct 2023
NCT01460654 (CTgov)	Phase 2	Hypogonadism \| Osteoporosis	44	Alendronate+Placebo Testosterone (Alendronate and Placebo Testosterone)	frvspybjkz(kiemvjlqvi) = vffyivrlqp enjlghajwv (oglctfruks, zrwhwheusi - tztvnnpzld) View more	-	12 Oct 2023
WCO_IOF_ESCEO2023	Not Applicable	Osteoporosis, Postmenopausal	-	Weekly Gastro-resistant Risedronate 35 mg	nfurcergdk(zjbunesbiw) = spkflwwdrg ygjarjilzf (mubaccuzgh, 75 - 82) View more	Positive	04 May 2023

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