Drugs / Zoledronate
last change Jun 2026 re-read 2 minutes ago

Zoledronate

also known as zol · Zolendronic acid · AXS-02

Other / unclassified

Developed for
breast cancer · osteoporosis · acute lymphoblastic leukemia · acute myeloid leukemia · cervical cancer · complex regional pain syndrome type 1 · disease related to hematopoietic stem cell transplant · Ewing sarcoma
+17 more · Hodgkins lymphoma · humoral hypercalcemia of malignancy · metastatic malignant neoplasm · myelodysplastic syndrome · neuroblastoma · osteosarcoma · pneumonia · postmenopausal osteoporosis · precancerous condition · prostate cancer · renal cell carcinoma · rhabdomyosarcoma · triple-negative breast carcinoma · castration-resistant prostate carcinoma · metastatic neoplasm · plasma cell myeloma · spondylolisthesis
Investigated by
Associazione Italiana per la Ricerca sul Cancro · Mario Negri Institute for Pharmacological Research · National Cancer Institute (NCI) · Axsome Therapeutics, Inc. · Barbara Ann Karmanos Cancer Institute · Caritas Medical Centre, Hong Kong
+19 more · Children's Cancer Hospital Egypt 57357 · Children's Hospital Medical Center, Cincinnati · First Affiliated Hospital, Sun Yat-Sen University · HaEmek Medical Center, Israel · M.D. Anderson Cancer Center · Medical University of Vienna · National Institute of Allergy and Infectious Diseases (NIAID) · National Taiwan University Hospital · Novartis Pharmaceuticals · Prince of Wales Hospital, Shatin, Hong Kong · Queen Mary Hospital, Hong Kong · SWOG Cancer Research Network · Susanne Crocamo · The University of Hong Kong · United Christian Hospital · United States Department of Defense · University Hospital, Toulouse · University of California, San Francisco · University of Wisconsin, Madison

Trials 18 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07375290 Feb 2026 → Jan 2028 expected disease related to hematopoietic stem cell transplant Children's Hospital Medical Center, Cincinnati Recruiting No outcome recorded
Phase 1 NCT02508038 Feb 2016 → Dec 2026 expected Ewing sarcoma, Hodgkins lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia +4 University of Wisconsin, Madison Recruiting No outcome recorded
Phase 1 NCT00278434 Apr 2005 → Jul 2008 cervical cancer, precancerous condition University of California, San Francisco Terminated No outcome recorded
Phase 26 trials
Phase 2 NCT03358017 Mar 2018 → Jun 2021 triple-negative breast carcinoma Mario Negri Institute for Pharmacological Research Completed No outcome recorded
Phase 2 NCT02347163 Feb 2015 → Jun 2018 breast cancer Mario Negri Institute for Pharmacological Research Terminated No outcome recorded
Phase 2 NCT01472146 Oct 2011 → Jul 2016 breast cancer Susanne Crocamo Completed No outcome recorded
Phase 2 NCT01067989 Mar 2010 → Apr 2014 breast cancer HaEmek Medical Center, Israel Terminated No outcome recorded
Phase 2 NCT00490698 Oct 2006 → Jan 2012 renal cell carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2 NCT00102908 May 2005 → Oct 2007 HIV infectious disease, osteoporosis National Institute of Allergy and Infectious Diseases (NIAID) Unknown No outcome recorded
Phase 33 trials
Phase 3 NCT02504008 Jul 2015 → Jan 2019 complex regional pain syndrome type 1 Axsome Therapeutics, Inc. Unknown No outcome recorded
Phase 3 NCT01656512 Oct 2011 → Jan 2014 osteoporosis Children's Cancer Hospital Egypt 57357 Completed No outcome recorded
Phase 3 NCT00301886 May 2006 breast cancer, humoral hypercalcemia of malignancy, metastatic malignant neoplasm SWOG Cancer Research Network Withdrawn No outcome recorded
Phase 43 trials
Phase 4 NCT06767150 Oct 2025 → Oct 2030 expected postmenopausal osteoporosis University Hospital, Toulouse Recruiting No outcome recorded
Phase 4 NCT05743179 Dec 2022 → May 2025 pneumonia The 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 not applicable3 trials
NCT01623908 Jul 2011 → Jun 2013 breast cancer, osteoporosis First Affiliated Hospital, Sun Yat-Sen University Terminated No outcome recorded
NCT01205646 Sep 2010 → Aug 2013 prostate cancer Barbara Ann Karmanos Cancer Institute Completed No outcome recorded
NCT00302484 Apr 2002 → ? osteoporosis Medical University of Vienna Unknown No outcome recorded
Also used as a comparator or background therapy in 10 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05400603 Background Nov 2023 → Dec 2026 expected neuroblastoma, osteosarcoma Emory University Recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT00213980 Comparator Jan 2000 → Apr 2008 breast cancer University of Wisconsin, Madison Completed No outcome recorded
Phase 32 trials
Phase 3 NCT05638399 Comparator Jan 2020 → Feb 2023 spondylolisthesis Shenzhen People's Hospital Unknown No outcome recorded
Phase 3 NCT02739594 Comparator Feb 2006 → Apr 2009 plasma cell myeloma Hoffmann-La Roche Terminated No outcome recorded
Phase 46 trials
Phase 4 NCT07281586 Background Jan 2026 → Dec 2028 expected osteoporosis National Taiwan University Hospital Recruiting No outcome recorded
Phase 4 NCT06059222 Comparator Oct 2023 → Aug 2030 expected osteoporosis University of Aarhus Recruiting No outcome recorded
Phase 4 NCT05655013 Comparator May 2023 → Feb 2027 expected postmenopausal osteoporosis Aarhus University Hospital Active not recruiting No outcome recorded
Phase 4 NCT04549207 Comparator Oct 2020 → Apr 2025 overdue breast cancer, castration-resistant prostate carcinoma Ottawa Hospital Research Institute Active not recruiting No outcome recorded
Phase 4 NCT03664687 Comparator Oct 2018 → Apr 2020 breast cancer Ottawa Hospital Research Institute Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

FieldValueCited text
Known as zoledronate “Investigator propose an open-label randomized superiority strategy trial to compare the 1-year lumbar densitometric efficacy of biomarkers-driven zoledronate (ZOL) infusion vs...” NCT06767150
25

ZoledronateNCT04549207

NCT02508038

NCT05400603

NCT05655013

NCT00102908

NCT05638399

NCT02739594

NCT05743179

NCT06059222

NCT00213980

NCT02721433

NCT01623908

NCT00301886

NCT01067989

NCT03664687

NCT02504008

NCT00302484

NCT02347163

NCT00278434

NCT07281586

NCT03358017

NCT00490698

NCT05091099

NCT07375290

NCT01205646

Known as AXS-02 AXS-02 (oral zoledronate)” NCT02504008
Known as zol zoledronate (zol)” NCT03358017
1

NCT06767150

Known as Zolendronic acid “Drug: zolendronic acid Zolendronic acid 4mg IV every 21 days for 8 cycles combine with chemotherapy” NCT01472146
1

NCT01656512

Action Inhibit “BPs are mevalonate pathway inhibitors” NCT02347163
Modality Other / unclassified “an investigational bisphosphonate” NCT00102908
Route Intravenous “single IV dose of zoledronate” NCT00102908