Alendronic Acid
Small molecule targets FDPS via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | FOSAMAX | — | 1997-04-25 – 2005-12-21 | fda.gov ↗ |
| Approved | EU (EMA) | Fosavance | — | 2005-08-24 | europa.eu ↗ |
| Approved | US (FDA) | FOSAMAX | — | 1995-09-29 | fda.gov ↗ |
Trials 91 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT06772792 | Apr → Jun 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02781805 | Aug 2016 → Dec 2018 | breast neoplasm | University of Wisconsin, Madison | Terminated | No outcome recorded |
| Phase 1 | NCT02057263 | Apr 2014 → Feb 2016 | hepatitis B virus infection | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01526278 | Oct 2011 → Jul 2012 | osteoporosis | Yuyu Pharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00641771 | May 2004 → Aug 2005 | osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 1 | NCT01012934 | Jul → Aug 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00835406 | Jun → Jul 2000 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07245381 | Dec 2025 → Aug 2026 overdue | cervical cancer | Dr. Itay GoorAryeh | Not yet recruiting | No outcome recorded |
| Phase 221 trials · 3 missed | ||||||
| Phase 2 | NCT07216794 | Jul 2026 → Mar 2027 expected | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT06016634 | Mar 2026 → Sep 2027 expected | avascular necrosis, ischemic disease, sickle cell disease | University of California, Davis | Recruiting | No outcome recorded |
| Phase 2 | NCT04708886 | Mar 2021 → Jun 2024 | osteoporosis, paraplegia, spinal cord injury | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT04403698 | Nov 2019 → Mar 2022 | arthropathy, erosive | University Hospital, Ghent | Completed | Mixed |
| Phase 2 | NCT01968850 | Apr 2014 → Mar 2018 | HIV infectious disease | Unity Health Toronto | Completed | No outcome recorded |
| Phase 2 | NCT02195895 | Apr 2014 → Aug 2016 | osteoporosis, spinal cord injury | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT01460654 | Oct 2011 → May 2014 | hypogonadism, osteoporosis | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT00921557 | Nov 2009 → Jan 2016 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
| Phase 2 | NCT00996801 | Nov 2009 → Jun 2011 | postmenopausal osteoporosis | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 2 | NCT02168543 | Mar 2009 → Jan 2011 | chronic periodontitis | Government Dental College and Research Institute, Bangalore | Completed | No outcome recorded |
| Phase 2 | NCT00532337 | Oct 2007 → Jul 2010 | osteoporosis | Ono Pharma USA Inc | Completed | No outcome recorded |
| Phase 2 | NCT00668941 | Sep 2005 → Feb 2016 | osteoporosis | Helen Hayes Hospital | Unknown | Missed primary |
| Phase 2 | NCT00259857 | Oct 2003 → Mar 2008 | osteoporosis | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT00010439 | Sep 2000 → Oct 2003 | osteoporosis | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT00005005 | Oct 1999 → Nov 2007 | osteoporosis | Dennis Black | Completed | Missed primary |
| Phase 2 | NCT00000400 | Aug 1999 → Apr 2006 | osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00019695 | Mar 1999 → Mar 2005 | metastatic carcinoma in the bone, prostate adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT00004488 | Oct 1998 → Sep 2002 | Gaucher disease, osteoporosis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT00001728 | Aug 1998 → Aug 2007 | polyostotic fibrous dysplasia | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | Mixed |
| Phase 2 | NCT00001720 | Mar 1998 → Jun 2003 | osteoporosis | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 2 | NCT00061256 | ? → Sep 2006 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/35 trials · 1 met primary · 1 missed | ||||||
| Phase 2/3 | NCT04169698 | Oct 2019 → May 2021 | disease related to solid organ transplantation, osteoporosis | Ain Shams University | Completed | Met primary |
| Phase 2/3 | NCT02230332 | Jan 2015 → Sep 2016 | asthma | Milton S. Hershey Medical Center | Completed | Missed primary |
| Phase 2/3 | NCT00297830 | Nov 2005 → Apr 2010 | bone resorption disease | Columbia University | Completed | No outcome recorded |
| Phase 2/3 | NCT00277251 | Mar 2003 → Jun 2006 | corticosteroid-induced osteoporosis | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT00209469 | Jul 2002 → Feb 2007 | osteoporosis | Glaser Pediatric Research Network | Unknown | No outcome recorded |
| Phase 330 trials · 6 met primary · 1 missed | ||||||
| Phase 3 | NCT07435051 | May 2026 → Dec 2029 expected | osteomyelitis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05602493 | Nov 2022 → Oct 2024 overdue | alveolar periostitis | Xeolas Pharmaceuticals Limited | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05305183 | May 2022 → May 2023 | osteoporosis | Shandong New Time Pharmaceutical Co., LTD | Unknown | No outcome recorded |
| Phase 3 | NCT01657162 | Nov 2012 → Oct 2016 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01631214 | May 2012 → Feb 2017 | postmenopausal osteoporosis | Amgen | Completed | Met primary |
| Phase 3 | NCT01437111 | Oct 2011 → Dec 2012 | osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00822029 | Feb 2009 → Feb 2011 | cerebral palsy, osteoporosis | Department of Clinical Research and Innovation | Terminated | No outcome recorded |
| Phase 3 | NCT00692913 | Jun 2008 → Jul 2010 | osteoporosis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00518531 | Sep 2007 → Jun 2009 | osteoporosis | Amgen | Completed | Met primary |
| Phase 3 | NCT00421343 | Feb 2007 → Jun 2008 | osteoporosis | Hebrew SeniorLife | Completed | No outcome recorded |
| Phase 3 | NCT00400530 | Dec 2005 → ? | osteoporosis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00122356 | Sep 2005 → Feb 2013 | breast cancer | Barwon Health | Completed | No outcome recorded |
| Phase 3 | NCT00120757 | Oct 2004 → Nov 2008 | HIV infectious disease, osteoporosis | French National Agency for Research on AIDS and Viral Hepatitis | Completed | Met primary |
| Phase 3 | NCT00092079 | Jan → Nov 2004 | osteoporosis, vitamin D deficiency | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092066 | Sep 2003 → May 2004 | osteoporosis, vitamin D deficiency | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092027 | Mar 2003 → Mar 2004 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092040 | Mar 2003 → Oct 2004 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00346190 | Jan 2003 → Apr 2007 | osteoporosis | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 3 | NCT00092014 | Sep 2002 → Apr 2004 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00048841 | May 2002 → Dec 2005 | hypogonadism, osteoporosis, prostate cancer | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 3 | NCT00177619 | May 2002 → Dec 2005 | prostate cancer | University of Pittsburgh | Completed | No outcome recorded |
| Phase 3 | NCT00136058 | Jan 2002 → Apr 2006 | osteoporosis | University of Alberta | Completed | No outcome recorded |
| Phase 3 | NCT00480662 | Oct 2001 → Oct 2002 | bone Paget disease | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00480766 | Jul 2001 → Aug 2003 | osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00389740 | Apr 2001 → Jan 2003 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00138983 | May 2000 → Nov 2003 | granulomatosis with polyangiitis, polymyalgia rheumatica, polymyositis, rheumatoid arthritis +1 | UMC Utrecht | Completed | Met primary |
| Phase 3 | NCT00000430 | Oct 1999 → Sep 2004 | osteoporosis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Terminated | No outcome recorded |
| Phase 3 | NCT00000427 | Sep 1999 → Oct 2005 | osteoporosis | Massachusetts General Hospital | Completed | Met primary |
| Phase 3 | NCT00398931 | Feb 1998 → Oct 2003 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00398606 | Apr 1995 → Feb 1998 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 422 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT06864130 | Feb 2025 → Mar 2029 expected | postmenopausal osteoporosis | Odense University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06264609 | Feb 2024 → Dec 2029 expected | osteoporosis | Paul F Netzel | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05764733 | Jun 2023 → Jan 2028 expected | bone resorption disease | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT05527548 | Dec 2022 → Oct 2025 | — | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 4 | NCT05091099 | Jan 2022 → Nov 2025 | osteoporosis | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05325515 | Oct 2021 → Sep 2022 | osteoporosis | Aarhus University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04739592 | Jul 2021 → Jul 2023 | osteoarthritis, knee | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05387200 | Jul 2021 → May 2023 | osteoporosis | Yonsei University | Unknown | Met primary |
| Phase 4 | NCT02795546 | Jan 2015 → Apr 2016 | periodontal disorder | Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre | Completed | No outcome recorded |
| Phase 4 | NCT02470611 | Nov 2012 → Nov 2013 | bone resorption disease, chronic periodontitis | Federal University of Minas Gerais | Completed | No outcome recorded |
| Phase 4 | NCT01350934 | Jun 2011 → Jan 2013 | postmenopausal osteoporosis | Organon and Co | Completed | Met primary |
| Phase 4 | NCT02417389 | May 2008 → Oct 2011 | osteoporosis, primary hyperparathyroidism | Istituto Auxologico Italiano | Completed | No outcome recorded |
| Phase 4 | NCT02303873 | Mar 2007 → Jul 2011 | osteogenesis imperfecta | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00299572 | Mar → Dec 2006 | — | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00261625 | Aug 2005 → Oct 2007 | end stage renal failure, osteoporosis | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00265252 | Jun 2005 → Jun 2008 | osteonecrosis | Kaohsiung Medical University Chung-Ho Memorial Hospital | Unknown | Missed primary |
| Phase 4 | NCT00327990 | Apr 2005 → Dec 2006 | osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00079924 | Nov 2004 → May 2007 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT02598440 | Mar 2004 → May 2005 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT01882400 | May 2001 → Sep 2007 | cystic fibrosis, muscular dystrophy, osteoporosis | Gilles Boire | Completed | No outcome recorded |
| Phase 4 | NCT00006180 | Aug 2000 → Jan 2007 | major depressive disorder, osteoporosis | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 4 | NCT00035971 | — | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 missed | ||||||
| — | NCT02440581 | Jul 2015 → Jun 2021 | chronic renal failure syndrome | Hartmut Malluche, MD | Completed | Missed primary |
| — | NCT01889134 | Jan 2009 → Jun 2012 | primary hyperparathyroidism | Wroclaw Medical University | Completed | No outcome recorded |
| — | NCT00145977 | Jul 2001 → Dec 2009 | osteoporosis | University of Chicago | Completed | No outcome recorded |
| — | NCT00004489 | Oct 1998 → Sep 2002 | cystic fibrosis, osteoporosis | University of North Carolina | Completed | No outcome recorded |
| — | NCT00936260 | Jan 1998 → Dec 2004 | osteoporosis | Ciudad Universitaria, Spain | Completed | No outcome recorded |
| Comparator or background therapy69 trials | ||||||
| Phase 1 | NCT00577850 Comparator | Nov 2002 → Feb 2004 | osteoporosis | Warner Chilcott | Completed | No outcome recorded |
| Phase 1 | NCT00983996 Comparator | Jun → Jul 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT04140006 Comparator | Jul 2019 → Jul 2020 | — | University of Baghdad | Unknown | No outcome recorded |
| Phase 2 | NCT06973109 Comparator | Jun 2026 → Mar 2027 | postmenopausal osteoporosis | University of Pittsburgh | Withdrawn | No outcome recorded |
| Phase 2 | NCT07471880 Comparator | Dec 2024 → Oct 2026 expected | secondary avascular necrosis | ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05397938 Comparator | Jun → Jul 2022 | glucocorticoid-induced osteoporosis | Shanghai JMT-Bio Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT03980847 Comparator | Feb 2018 → Mar 2019 | bone resorption disease | Islamic Azad University, Sanandaj | Completed | No outcome recorded |
| Phase 2 | NCT03396315 Comparator | Jan 2018 → Jun 2023 | osteoporosis | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT02944799 Comparator | Dec 2015 → Dec 2021 | osteoporosis, rheumatoid arthritis | University of Aarhus | Completed | No outcome recorded |
| Phase 2 | NCT02132026 Comparator | Nov 2014 → Nov 2019 | aortic valve stenosis | University of Edinburgh | Completed | No outcome recorded |
| Phase 2 | NCT00896532 Comparator | Jun 2009 → Feb 2011 | postmenopausal osteoporosis | Amgen | Completed | Met primary |
| Phase 2 | NCT00471237 Comparator | May 2007 → Dec 2008 | osteoporosis | GlaxoSmithKline | Terminated | Met primary |
| Phase 2 | NCT00666627 Comparator | Apr 2007 → Sep 2012 | postmenopausal osteoporosis | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT00293813 Comparator | May 2006 → Mar 2008 | postmenopausal osteoporosis | Amgen | Completed | Met primary |
| Phase 2 | NCT00043186 Comparator | May 2002 → Apr 2007 | osteoporosis | Amgen | Completed | Met primary |
| Phase 2 | NCT00005006 Comparator | Sep 1987 → Feb 2003 | osteoporosis | Helen Hayes Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT03040531 Comparator | Jan 2017 → Jun 2018 | corticosteroid-induced osteoporosis | University of Messina | Unknown | No outcome recorded |
| Phase 2/3 | NCT03204097 Comparator | Mar 2016 → Feb 2017 | chronic periodontitis | Government Dental College and Research Institute, Bangalore | Completed | No outcome recorded |
| Phase 2/3 | NCT02455869 Comparator | Jul 2014 → Mar 2015 | chronic periodontitis | Government Dental College and Research Institute, Bangalore | Completed | No outcome recorded |
| Phase 2/3 | NCT02461667 Comparator | Jul 2014 → Mar 2015 | chronic periodontitis | Government Dental College and Research Institute, Bangalore | Completed | No outcome recorded |
| Phase 3 | NCT07028320 Comparator | Dec 2021 → Dec 2023 | postmenopausal osteoporosis | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03292146 Background | Oct 2017 → Jul 2021 | anorexia nervosa, bone resorption disease | Massachusetts General Hospital | Completed | Met primary |
| Phase 3 | NCT04704947 Background | Oct 2017 → Oct 2030 expected | poisoning | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT01552122 Comparator | May 2012 → Feb 2015 | postmenopausal osteoporosis | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT01512446 Comparator | Feb 2012 → Mar 2013 | osteoporosis | Evangelisches Krankenhaus Lutherhaus gGmbH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00680953 Comparator | May 2008 → Jun 2012 | osteoporosis | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT00463268 Comparator | Sep 2007 → Jan 2012 | osteoporosis | University Hospital of Mont-Godinne | Completed | No outcome recorded |
| Phase 3 | NCT00404820 Comparator | Oct 2006 → Dec 2008 | osteoporosis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00377819 Comparator | Sep 2006 → Mar 2008 | postmenopausal osteoporosis | Amgen | Completed | Met primary |
| Phase 3 | NCT00330460 Comparator | May 2006 → Nov 2007 | osteoporosis | Amgen | Completed | Met primary |
| Phase 3 | NCT00391404 Comparator | May 2006 → Oct 2008 | osteoporosis | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT00354302 Background | Apr 2006 → Mar 2011 | female breast carcinoma, osteoporosis | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 3 | NCT00236002 Comparator | Jul 2005 → Nov 2007 | osteoporosis | Canadian Urology Research Consortium | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00051558 Comparator | Nov 2002 → Jul 2006 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT01812551 Comparator | Oct 2002 → Jul 2006 | cystic fibrosis, osteoporosis | Istituto Auxologico Italiano | Completed | No outcome recorded |
| Phase 3 | NCT00000412 Comparator | Sep 1997 → Apr 2002 | osteoporosis | Columbia University | Completed | No outcome recorded |
| Phase 4 | NCT06856369 Comparator | Jan 2025 → Feb 2026 overdue | chronic periodontitis | Bahria University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05645289 Comparator | Jan → Dec 2023 | postmenopausal osteoporosis | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05493761 Comparator | Dec 2022 → Jul 2026 overdue | NAFLD1, postmenopausal osteoporosis | Aristotle University Of Thessaloniki | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05151484 Comparator | Mar 2022 → Jan 2027 expected | osteoporosis | Madhumathi Rao | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04177940 Comparator | Aug 2020 → Jul 2024 | osteoporosis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT03623633 Comparator | Nov 2018 → Feb 2023 overdue | postmenopausal osteoporosis | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03005678 Comparator | Apr 2017 → Nov 2019 | osteoporosis | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03006003 Comparator | Jan 2017 → Dec 2021 | depressive disorder | Taichung Veterans General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02322099 Comparator | May 2016 → Sep 2019 | disease of bone structure | University College Dublin | Terminated | No outcome recorded |
| Phase 4 | NCT02139007 Comparator | Jun 2014 → Jun 2016 | osteoporosis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT02371252 Comparator | Apr 2014 → Dec 2016 | osteoporosis | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT01750086 Comparator | Jan 2013 → Apr 2014 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01770106 Comparator | Dec 2012 → Jun 2014 | rheumatoid arthritis | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT00713258 Comparator | Apr 2008 → May 2010 | — | Nycomed | Terminated | No outcome recorded |
| Phase 4 | NCT00729651 Comparator | Mar 2008 → Apr 2009 | postmenopausal osteoporosis | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00503113 Comparator | Jul 2007 → Apr 2010 | postmenopausal osteoporosis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 4 | NCT00395382 Comparator | Jan 2007 → Sep 2009 | arteriosclerosis disorder, calcinosis | Monash University | Completed | No outcome recorded |
| Phase 4 | NCT00359385 Comparator | Jul 2006 → Sep 2009 | primary hyperparathyroidism | Columbia University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00460057 Comparator | Mar → Dec 2006 | osteoporosis | Eulji University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01535027 Comparator | Mar 2006 → Dec 2012 | osteoporosis | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00504166 Comparator | Feb 2006 → Mar 2009 | osteoporosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT00727493 Comparator | Jan 2004 → Jan 2010 | osteoporosis | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 4 | NCT00157690 Comparator | Dec 2003 → Aug 2006 | cystic fibrosis, osteoporosis | McMaster University | Completed | No outcome recorded |
| Phase 4 | NCT02416271 Comparator | Apr 2001 → May 2003 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00159419 Comparator | Aug 1999 → Aug 2008 | bone Paget disease, osteogenesis imperfecta, osteoporosis | Indiana University | Completed | No outcome recorded |
| — | NCT07242612 Comparator | Oct 2025 → Mar 2026 overdue | postmenopausal osteoporosis | Khyber Medical University Peshawar | Recruiting | No outcome recorded |
| — | NCT04555317 Background | May 2021 → Aug 2025 | female reproductive organ cancer | The Christie NHS Foundation Trust | Unknown | No outcome recorded |
| — | NCT05662358 Comparator | Jan 2021 → Sep 2023 | drug pseudoallergy | Shenzhen People's Hospital | Unknown | No outcome recorded |
| — | NCT02304757 Comparator | Jan 2015 → Dec 2019 | differentiated thyroid carcinoma, osteoporosis | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| — | NCT01656629 Comparator | Aug 2012 → Jun 2014 | osteoporosis | Johns Hopkins University | Terminated | No outcome recorded Stop: Business |
| — | NCT01131884 Comparator | Jun 2010 → Dec 2012 | osteoporosis, spinal cord injury | University of Rochester | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01020253 Comparator | Jan 2006 → Apr 2008 | bone disorder | Yokohama City University Medical Center | Unknown | No outcome recorded |
| — | NCT00580047 Comparator | Dec 2003 → Jul 2014 | impaired renal function disease | University of Nebraska | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2023-05-08 | Amgen | Results NEW DATA FROM AMGEN'S PROLIA® (DENOSUMAB) DEMONSTRATES SIGNIFICANT REDUCTION IN OSTEOPOROTIC FRACTURE RISK COMPARED TO ALENDRONATE amgen.com ↗
Treatment with Prolia was also associated with greater reductions in fracture risk over time. |
| 2021-02-15 | EffRx Pharmaceuticals SA | Results EffRx Pharmaceuticals Announces the Release of Binosto® Data in Two Publications effrx.com ↗
FREIENBACH, Switzerland – EffRx Pharmaceuticals SA, a commercial-stage company that commercializes niche and orphan medicines in Switzerland and Europe, today announced the publication of new scientific data on its Binosto ® (buffered soluble alendronate). |
| 2017-09-11 | Amgen | Results EVENITY™ (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine amgen.com ↗
The results were simultaneously published in the New England Journal of Medicine (NEJM) and presented today as a late-breaking abstract at an oral scientific session at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR) in Denver. |
| 2017-06-15 | Yuyu Pharma, Inc. | Results 유유제약, 골다공증 치료제 맥스마빌정 임상4상 골절예방효과 입증 yuyu.co.kr ↗
위 환자를 대상으로 맥스마빌정 투여 후 12개월 추적 관찰한 결과, 골다공증성 골절 발생율은 약 2.7%였고, 요추 골밀도 및 고관절 골밀도는 각각 5% 및 1.5% 개선되었다. |
| 2008-09-12 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma gets USFDA approval for generic Fosamax® tablets sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for generic Fosamax ®, alendronate sodium tablets. |
| 2008-02-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Generic Fosamax® Tablets tevapharm.com ↗
the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's osteoporosis treatment Fosamax® (Alendronate Sodium) Tablets, 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. |
| 2007-11-14 | Eli Lilly and Company | Results FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis lilly.com ↗
In this head-to-head comparator study, the increase in lumbar spine BMD was significantly greater in patients receiving teriparatide compared with alendronate at 6, 12, and 18 months of treatment (p 0.001 at all time points). |
| 2005-08-08 | Eli Lilly and Company | Results New Study Provides In-Depth Look at How Osteoporosis Treatments Function Within Bone lilly.com ↗
The study, which provides more in-depth information than previously available about these two treatments, found that both therapies increase bone mineral density (BMD), but to different degrees and through different means. |
| 2002-12-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Alendronate Sodium Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted tentative approval for the company's ANDA for Alendronate Sodium Tablets, 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. |
All press releases naming this drug 38 releases
Evidence & citations 33 cited values
Every value below carries the sentence it was read from. 166 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alendronic Acid | “Topical Alendronic Acid on Alveolar Bone Remodeling After Tooth Extraction” NCT05602493 ↗ |
| Known as | Acide alendronique | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | Acido alendronico | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | Adrovance | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | alendronate | “The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are...” NCT00122356 ↗148“This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D₃ (ALN/D5600) to alendronate 70 mg without additional vit-D...” PMID 24719139 ↗ Apr 2014 “Postmenopausal women with osteoporosis on alendronate or raloxifene for at least 18 months added teriparatide (Add groups) or switched to teriparatide (Switch groups) for 18 months.” PMID 19584192 ↗ Jul 2009 “Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D.” PMID 19487264 ↗ Jun 2009 “Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)” NCT04177940 ↗ “A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)” NCT00389740 ↗ “Alendronate Sodium trihydrate, m.w 325.12, Pharmaceutical Secondary standard, PHR 1599” NCT04140006 ↗ “This study compared liquid and tablet forms of alendronate for osteoporosis treatment.” PMID 39589664 ↗ Nov 2024 “1. Bisphosphonates: fasting oral alendronate 70mg/w for 24 weeks.” NCT07435051 ↗ “Alendronate 70mg once weekly / 24 mos” NCT00532337 ↗ “Alendronate 5mg + calcitriol 0.5 μg” NCT01526278 ↗ |
| Known as | Alendronate (as sodium) | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | alendronate sodium | “We will enroll patients who have undergone cardiac transplantation into a randomized, double-blind, 12-month study of the efficacy and safety of calcitriol (Rocaltrol) and...” NCT00000412 ↗19“an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women” NCT00092027 ↗ “70 mg alendronate sodium tablet weekly and a minodronate tablet matching placebo monthly for 48 weeks.” NCT05305183 ↗ “MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks” NCT00092079 ↗ “One bisphosphonate, namely alendronate sodium (or alendronate) is chosen” NCT01770106 ↗ “MK0217, alendronate sodium / Duration of Treatment : 2 Years” NCT00398606 ↗ “MK0217, alendronate sodium / Duration of Treatment : 5 Years” NCT00398931 ↗ “MK0217, alendronate sodium / Duration of Treatment: 1 Month” NCT00400530 ↗ “MK0217, alendronate sodium/Duration of Intervention: 12 mo” NCT00092040 ↗ “Alendronate Sodium Tablets, 70 mg” NCT01012934 ↗ “Alendronate Sodium Tablets, 10 mg” NCT00983996 ↗ |
| Known as | Alendronate sodium component of fosamax plus d | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | Alendronate sodium hydrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00680953 ↗ |
| Known as | Alendronate Sodium Tablets | “Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo” NCT05305183 ↗ |
| Known as | Alendronate sodium trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | Alendronic acid monosodium salt trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | ALN | “This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D₃ (ALN/D5600) to alendronate 70 mg without additional vit-D...” PMID 24719139 ↗ Apr 201410“In the Fracture Intervention Trial (FIT) Long Term Extension (FLEX) Trial, 10 years of alendronate (ALN) did not significantly reduce the risk of nonvertebral fractures (NVFs)...” PMID 20200926 ↗ May 2010 “METHODS: This randomized, active and placebo-controlled, dose-ranging study enrolled 526 postmenopausal women, who had taken alendronate (ALN) for ≥12 months preceding the...” PMID 26556736 ↗ Nov 2015 “During a 2-year extension, women in the daily TPTD group were switched to alendronate (ALN) and those in the cyclic TPTD group continued on cyclic TPTD (without any ALN).” PMID 36410666 ↗ Nov 2022 “Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket” NCT02461667 ↗ “Locally delivered Alendronate (ALN) have potent inhibitory effect on bone” NCT02168543 ↗ “Denosumab (DMAB) to Alendronate (ALN)” NCT04177940 ↗ “with drugs like alendronate (ALN).” NCT01656629 ↗ “Alendronate Gel (ALN)” NCT04140006 ↗ “Alendronate (ALN)” NCT05527548 ↗ “alendronate (ALN)” NCT07216794 ↗ |
| Known as | ALN OW | “Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D.” PMID 19487264 ↗ Jun 2009 |
| Known as | ALN-S | “once-weekly low-volume liquid alendronate sodium trihydrate (ALN-S), an oral solution, to once-weekly alendronate sodium (ALN-T), an oral tablet” PMID 39589664 ↗ Nov 2024 |
| Known as | ALN-T | “once-weekly low-volume liquid alendronate sodium trihydrate (ALN-S), an oral solution, to once-weekly alendronate sodium (ALN-T), an oral tablet” PMID 39589664 ↗ Nov 2024 |
| Known as | Binosto | “Binosto (effervescent and buffered alendronate)” NCT05325515 ↗ |
| Known as | Fosamax | “The overall goal of this proposal is to determine the effectiveness and safety of once weekly alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with...” NCT00177619 ↗18“We will enroll patients who have undergone cardiac transplantation into a randomized, double-blind, 12-month study of the efficacy and safety of calcitriol (Rocaltrol) and...” NCT00000412 ↗ “To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to...” NCT00400530 ↗ “The potent bisphosphonate, alendronate (Fosamax), reduces bone remodeling and enhances secondary mineralization.” NCT00359385 ↗ “treatment of glucocorticoid-associated osteopenia and osteoporosis with 18 months of alendronate (FOSAMAX®)” NCT00209469 ↗ “Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp \& Dohme.LTD.).” NCT02303873 ↗ “Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down).” NCT00001720 ↗ “Fosamax (aledronate sodium 70mg, oral tablet)” NCT05387200 ↗ “Comparator: Alendronate sodium (Fosamax)” NCT00729651 ↗ “Alendronate (Fosamax) 70mg every week.” NCT01460654 ↗ “Fosamax (conventional alendronate)” NCT05325515 ↗ |
| Known as | Fosavance | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | G-704,650 | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | Masibone S | “Masibone S (alendronate sodium trihydrate 70mg, oral solution)” NCT05387200 ↗ |
| Known as | MK-217 | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | MK0217 | “MK0217, alendronate sodium / Duration of Treatment : 2 Years” NCT00398606 ↗3“MK0217, alendronate sodium / Duration of Treatment : 5 Years” NCT00398931 ↗ “MK0217, alendronate sodium / Duration of Treatment: 1 Month” NCT00400530 ↗ “MK0217, alendronate sodium/Duration of Intervention: 12 mo” NCT00092040 ↗ |
| Known as | NSC-722597 | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | NSC-758931 | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | Sedron | “Sedron (alendronate) 70 mg taken orally once a week for 12 months” NCT01889134 ↗ |
| Known as | Sodium alendronate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02470611 ↗ |
| Known as | Sodium alendronate trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Known as | Vantavo | ChEMBL registry synonym — accepted as the source's own label CHEMBL870 ↗ |
| Action | Inhibit | “Alendronate is a drug that blocks or reduces bone loss” NCT00000427 ↗1“Farnesyl diphosphate synthase inhibitor” CHEMBL870 ↗ |
| Modality | Small molecule | “a bisphosphonate, alendronate (ALN)” NCT00000430 ↗ |
| Route | Oral | “70 mg/week by oral route” NCT00000400 ↗ |
| Target | FDPS | “Farnesyl diphosphate synthase inhibitor” CHEMBL870 ↗ |