Zoledronic acid monohydrate Clinical Trials

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25mg	USD 147
1g	USD 370

Clinical Trials

Zoledronic acid monohydrate has been extensively investigated across numerous clinical trials spanning Phase I through Phase IV. These studies evaluate therapeutic efficacy and pharmacokinetics across conditions such as postmenopausal osteoporosis, bone loss post-hematopoietic stem cell transplantation, low bone mineral density in idiopathic inflammatory myopathies, bone metastases, and metastatic leiomyosarcoma. Sponsored by academic medical centers, university hospitals, and pharmaceutical companies including Novartis and EUSA Pharma Inc., these trials encompass recruitment statuses ranging from active recruitment to completed and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06374459	RECRUITING	Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer	Washington University School of Medicine	2025-01-30	PHASE1; PHASE2
NCT06767150	RECRUITING	Postmenopausal Osteoporosis	University Hospital, Toulouse	2025-10-02	PHASE4
NCT07406685	RECRUITING	Postmenopausal Osteoporosis; Postmenopausal Osteopenia; Primary Osteoporosis; Osteoporosis	National Taiwan University Hospital	2026-08-20	PHASE4
NCT06625190	RECRUITING	Neuroblastoma; Rhabdomyosarcoma; Synovial Sarcoma; Peripheral Nerve Sheath Tumors; Clear Cell Sarcoma; Alveolar Soft Part Sarcoma; Desmoplastic Small Round Cell Tumor; Chordoma; Rhabdoid Tumor; Epithelioid Sarcoma; Myoepithelial Tumor; Osteosarcoma; Ewing Sarcoma; Wilms Tumor	University of Florida	2026-02-11	PHASE1; PHASE2
NCT07772609	NOT_YET_RECRUITING	Osteoporosis in Post-menopausal Women	Sahlgrenska University Hospital	2027-01-11	PHASE4
NCT07668583	NOT_YET_RECRUITING	Osteomyelitis Chronic	Assistance Publique - Hôpitaux de Paris	2026-09-15	PHASE2
NCT06118905	RECRUITING	Osteoporosis	Susan L. Greenspan	2024-02-08	PHASE4
NCT06762730	RECRUITING	HIV Infected Individuals; Osteopenia	Hadassah Medical Organization	2024-12-09	PHASE4
NCT06533865	RECRUITING	FHA (Functional Hypothalamic Amenorrhea)	Massachusetts General Hospital	2025-03-19	PHASE3
NCT06859580	RECRUITING	Primary Hyperparathyroidism	University of Aarhus	2025-03-01	PHASE4
NCT07056478	NOT_YET_RECRUITING	Sarcopenia in Elderly	Prince of Wales Hospital, Shatin, Hong Kong	2026-01-01	PHASE3
NCT03073785	ACTIVE_NOT_RECRUITING	Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage I Pancreatic Cancer AJCC v6 and v7; Stage IA Pancreatic Cancer AJCC v6 and v7; Stage IB Pancreatic Cancer AJCC v6 and v7; Stage II Pancreatic Cancer AJCC v6 and v7; Stage IIA Pancreatic Cancer AJCC v6 and v7; Stage IIB Pancreatic Cancer AJCC v6 and v7; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IV Pancreatic Cancer AJCC v6 and v7	University of Nebraska	2016-09-16	PHASE2
NCT07741136	NOT_YET_RECRUITING	Chronic Kidney Disease; Osteoporosis; Dialysis	University of Campinas, Brazil	2026-08-15	PHASE1
NCT06221072	NOT_YET_RECRUITING	Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors	Shanghai JMT-Bio Inc.	2024-04-05	PHASE3
NCT05058976	ACTIVE_NOT_RECRUITING	Osteoporosis; Osteoporosis, Postmenopausal; Osteoporosis Fracture	Susan L. Greenspan	2021-09-15	PHASE4
NCT04608630	RECRUITING	Critical Illness; Osteoporosis	Australian and New Zealand Intensive Care Research Centre	2021-07-15	PHASE2
NCT07471516	RECRUITING	Congenital Dyserythropoietic Anemia (CDA)	Institute of Hematology & Blood Diseases Hospital, China	2026-02-25	PHASE1; PHASE2
NCT05053750	ACTIVE_NOT_RECRUITING	Epithelial Ovarian; Fallopian Tube; Primary Peritoneal Cancer	M.D. Anderson Cancer Center	2021-12-14	EARLY_PHASE1
NCT03295981	RECRUITING	Giant Cell Tumor of Bone	St. Louis University	2018-05-03	PHASE3
NCT06513624	RECRUITING	With MSS/pMMR Advanced, Platinum-resistant Ovarian Cancer	National University Hospital, Singapore	2024-12-09	PHASE1
NCT06759064	RECRUITING	Cancer of Stomach, Adenocarcinoma; Ascites, Malignant	Qilu Hospital of Shandong University	2024-09-12	PHASE1; PHASE2
NCT05025293	COMPLETED	Hip Fractures; Osteoporosis	Lene Bergendal Solberg	2021-12-15	PHASE4
NCT05595603	RECRUITING	Giant Cell Tumor of Bone	Second Affiliated Hospital, Zhejiang University, School of Medicine	2023-03	PHASE2
NCT05906056	RECRUITING	Traumatic Brain Injury; Spinal Cord Injuries; Stroke	University of Ioannina	2023-05-12
NCT00268476	ACTIVE_NOT_RECRUITING	Prostate Cancer	Medical Research Council	2005-07-08	PHASE2; PHASE3
NCT03924414	COMPLETED	Parkinson Disease; Osteoporosis; Parkinsonism; Parkinson's Disease and Parkinsonism; Atypical Parkinsonism; Progressive Supranuclear Palsy; Multiple System Atrophy; Vascular Parkinsonism; Dementia With Lewy Bodies	California Pacific Medical Center Research Institute	2019-11-15	PHASE4
NCT05666310	ACTIVE_NOT_RECRUITING	Sarcopenia; Osteoporosis	Nami Safai Haeri	2023-02-14	PHASE4
NCT05904353	RECRUITING	Hip Fractures; Osteoporosis; Zoledronic Acid; Ambulant Nurse; Case Manager	University Hospital, Akershus	2024-01-01
NCT06876636	ACTIVE_NOT_RECRUITING	Breast Cancer Metastatic	Xijing Hospital	2025-03-10
NCT07546058	COMPLETED	Orthodontic Appliance Complication	Latakia University	2024-12-01
NCT05204836	TERMINATED	Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injuries; Osteo Arthritis Knee	University of Calgary	2023-05-16	PHASE1
NCT06135298	COMPLETED	Trochanteric Fracture of Femur; Osteoporotic Fracture of Femur; Hip Fractures; Bone Density, Low	Aksaray University	2023-12-01	PHASE4
NCT05677152	RECRUITING	Orthopedics; Traumatology	AUVA Traumazentrum Vienna Site UKH Meidling	2022-08-22	PHASE2
NCT03735537	COMPLETED	Osteogenesis Imperfecta	University of Edinburgh	2016-11-01	PHASE4
NCT05080790	COMPLETED	Leiomyosarcoma	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	2021-11-15	PHASE2
NCT05866172	UNKNOWN	Hepatocellular Carcinoma	Sun Yat-sen University	2023-05-10	PHASE3
NCT00412022	UNKNOWN	Breast Cancer	National Cancer Institute, Naples	2004-03	PHASE3
NCT04779216	COMPLETED	Bone Density, Low; Bone Loss; Anorexia Nervosa; Eating Disorders	Karen Klahr Miller, MD	2021-09-20	PHASE3
NCT04719650	UNKNOWN	Postmenopausal Osteoporosis	Peking University Third Hospital	2021-10	PHASE4
NCT02516423	TERMINATED	Solitary Osseous Plasmacytoma	Alliance for Clinical Trials in Oncology	2016-11-29	PHASE3
NCT04087096	COMPLETED	Bariatric Surgery Candidate; Bone Loss	Massachusetts General Hospital	2020-08-24	PHASE4
NCT04498715	UNKNOWN	Trochanteric Fracture of Femur	Lithuanian University of Health Sciences	2021-06-01
NCT05361408	COMPLETED	Osteoporosis	Yonsei University	2022-02-11	PHASE4
NCT04304755	COMPLETED	Neovascular Age-related Macular Degeneration	Oslo University Hospital	2021-10-25	PHASE2
NCT06051344	UNKNOWN	Primary Osteoarthritis	Toufiqe-E-Ealahi	2023-01-01	PHASE4
NCT04597931	UNKNOWN	Osteoporosis Fracture; Spinal Cord Injuries	Sheba Medical Center	2020-11-01	PHASE4
NCT04742010	COMPLETED	Bone Loss; Muscle Atrophy; Bariatric Surgery	Stinus Gadegaard Hansen	2021-02-20	PHASE2
NCT03951493	UNKNOWN	Vertebral Metastasis	Institut Cancerologie de l'Ouest	2020-06-23	PHASE3
NCT05164952	UNKNOWN	Use of Zoledronic Acid in Breast Cancer	Assiut University	2021-09-30	PHASE3
NCT03862833	COMPLETED	Hematopoietic Stem Cell Transplantation	Nantes University Hospital	2019-05-07	PHASE1
NCT03868033	COMPLETED	Osteoporosis	National Taiwan University Hospital	2019-04-12	PHASE4
NCT04303026	UNKNOWN	Osteoarthritis, Hip	Vestre Viken Hospital Trust	2020-03-02	PHASE3
NCT03396315	COMPLETED	IOP; Osteoporosis	Columbia University	2018-01-29	PHASE2
NCT04085419	UNKNOWN	Primary Hyperparathyroidism; Osteoporosis	University Medical Centre Ljubljana	2019-05-08	PHASE4
NCT03173976	ACTIVE_NOT_RECRUITING	Chondrosarcoma	Mohammed Milhem	2017-07-18	PHASE1
NCT05106517	UNKNOWN	Denosumab vs Zoledronate	Shenzhen People's Hospital	2021-09-08	PHASE2; PHASE3
NCT04253340	WITHDRAWN	Osteoporosis	University Hospital, Rouen	2020-03-01
NCT02286830	COMPLETED	Multiple Myeloma	Thomas Lund	2015-01	PHASE4
NCT04279392	COMPLETED	Bariatric Surgery Candidate; Bone Loss; Bone Resorption	University of Nebraska	2020-09-01	PHASE1; PHASE2
NCT03183557	UNKNOWN	Osteoporosis	Shinshu University	2017-10-12	PHASE2
NCT03930992	COMPLETED	Secondary Osteoporosis	University of Guadalajara	2019-04-17	PHASE3
NCT04652128	UNKNOWN	Stroke	Yonsei University	2019-07-15
NCT03336983	COMPLETED	Prostate Cancer; Bone Metastases	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	2017-12-01	PHASE2
NCT02589600	COMPLETED	Osteoporotic Fractures; Osteoporosis, Postmenopausal	Susan L. Greenspan	2016-01	PHASE4
NCT00916747	UNKNOWN	Progeria	Boston Children's Hospital	2009-08	PHASE2
NCT04115397	UNKNOWN	Seropositive Muskuloskeletal Complaints	Karolinska Institutet	2020-01	PHASE4
NCT05080790	Recruiting	Leiomyosarcoma	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest\|EUSA Pharma Inc.	2021-11-15	Phase 2
NCT04719481	Unknown status	Postmenopausal Osteoporosis	Peking University Third Hospital	2021-11	Phase 4
NCT04719481	UNKNOWN	Postmenopausal Osteoporosis	Peking University Third Hospital	2021-11	PHASE4
NCT04719650	Not yet recruiting	Postmenopausal Osteoporosis	Peking University Third Hospital	2021-10	Phase 4
NCT02480634	UNKNOWN	Non-small Cell Lung Cancer; Bone Metastasis	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	2019-06	PHASE4
NCT04325776	UNKNOWN	Bone Metastatic Non-small Cell Lung Cancer	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	2020-09-24	PHASE2
NCT04034199	UNKNOWN	Idiopathic Inflammatory Myopathies; Osteoporosis, Osteopenia	Kwong Wah Hospital	2019-08-15	PHASE3
NCT02069340	WITHDRAWN	Malignant Neoplasm; Musculoskeletal Complications	University of Southern California	2016-06
NCT00566618	COMPLETED	Breast Cancer; Bone Metastases	M.D. Anderson Cancer Center	2007-11-01	PHASE1; PHASE2
NCT02325414	COMPLETED	Spinal Cord Injury; Acute Spinal Cord Injury; Bone Loss; Osteoporosis	Northwestern University	2015-02	PHASE2
NCT03087851	COMPLETED	Osteoporosis	Aarhus University Hospital	2017-03-13	PHASE4
NCT01679080	TERMINATED	Osteogenesis Imperfecta	University of Aarhus	2012-11	PHASE2
NCT02632916	COMPLETED	Osteoporosis	Children's Hospital of Eastern Ontario	2016-08	PHASE2
NCT02176382	COMPLETED	Postmenopausal Osteoporosis	Massachusetts General Hospital	2014-08	PHASE4
NCT02333344	WITHDRAWN	Prosthetic Fixation After Cementless Total Hip Arthroplasty	Novartis Pharmaceuticals	2015-07-30	PHASE4
NCT03932071	UNKNOWN	Lung Metastases; Tumor Necrosis	Second Affiliated Hospital, Zhejiang University, School of Medicine	2017-01-01	PHASE4
NCT03424239	COMPLETED	Bariatric Surgery Candidate	Massachusetts General Hospital	2018-08-01	PHASE4
NCT03158246	UNKNOWN	Osteoporosis, Postmenopausal	Cttq	2017-06-01	PHASE4
NCT03118570	COMPLETED	Osteogenesis Imperfecta, Type I; Osteogenesis Imperfecta Type III; Osteogenesis Imperfecta Type IV	Ultragenyx Pharmaceutical Inc	2017-09-11	PHASE2
NCT04034199	Unknown status	Idiopathic Inflammatory Myopathies\|Osteoporosis Osteopenia	Kwong Wah Hospital\|Tung Wah Group of Hospitals	2019-08-15	Phase 3
NCT03576599	TERMINATED	Stress Fracture Foot; Stress Fracture Ankle	Oslo University Hospital	2017-06-29	PHASE4
NCT03862833	Completed	Hematopoietic Stem Cell Transplantation	Nantes University Hospital	2019-05-07	Phase 1
NCT03040765	TERMINATED	Thalassemia Majors (Beta-Thalassemia Major); Osteoporosis	Hamad Medical Corporation	2018-05-14	PHASE3
NCT01006395	COMPLETED	Prostate Cancer	Austin Health	2011-01	PHASE2; PHASE3
NCT00987636	COMPLETED	Ewing's Sarcoma	University Hospital Muenster	2009-10-01	PHASE3
NCT01197300	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2010-10-25	PHASE3
NCT03289338	COMPLETED	Charcot Arthropathy; Diabetes Complications	Post Graduate Institute of Medical Education and Research, Chandigarh	2016-06-01	PHASE2; PHASE3
NCT02499237	COMPLETED	Postmenopausal Osteoporosis	424 General Military Hospital	2015-07	PHASE4
NCT02595138	UNKNOWN	Triple Negative Breast Cancer	Chinese Academy of Medical Sciences	2015-10	PHASE3
NCT02123264	TERMINATED	Arthritis, Rheumatoid	Carmen Gómez-Vaquero	2014-05	PHASE3
NCT02739555	TERMINATED	Osteoid Osteoma	Assistance Publique - Hôpitaux de Paris	2016-06-23	PHASE3
NCT00799266	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2008-12-04	PHASE3
NCT02632903	WITHDRAWN	Osteoporosis; Osteonecrosis; Acute Lymphoblastic Leukemia	Children's Hospital of Eastern Ontario	2016-10	PHASE2
NCT02622607	UNKNOWN	Lung Cancer	Tang-Du Hospital	2013-01	PHASE3
NCT01642901	COMPLETED	Spinal Cord Injury	Thomas Jefferson University	2012-09	PHASE3
NCT01332617	WITHDRAWN	Myeloma	University of Louisville	2011-04	PHASE2
NCT00127205	COMPLETED	Breast Cancer	SWOG Cancer Research Network	2005-07	PHASE3
NCT02451462	WITHDRAWN	Hematopoietic Stem Cell Transplant; Bone Marrow Transplant	Stanford University	2015-09
NCT00193856	COMPLETED	Prostate Cancer	Trans Tasman Radiation Oncology Group	2003-10	PHASE3
NCT01228318	COMPLETED	HIV Infection; Bone Loss; Osteopenia; Osteoporosis	Emory University	2011-01	PHASE2
NCT02784652	COMPLETED	Bone Metastasis; Gastrointestinal Cancer	Severance Hospital	2014-06	PHASE2
NCT02274623	COMPLETED	Breast Cancer; Prostate Cancer; Bone Neoplasms; Hypocalcemia; Hyperparathyroidism, Secondary	OPKO Health, Inc.	2014-12	PHASE1
NCT01802658	TERMINATED	Bone Demineralization Lesions in the Injured Marrow	Nantes University Hospital	2012-11	PHASE3
NCT01772719	TERMINATED	Multiple Myeloma	University of Louisville	2012-08
NCT02517918	COMPLETED	Solid Tumor; Osteosarcoma	Institut Bergonié	2015-02	PHASE1
NCT01951586	COMPLETED	Non-Small Cell Lung Cancer	Amgen	2013-12-31	PHASE2
NCT01345019	COMPLETED	Cancer; Hematologic Malignancies; Multiple Myeloma; Oncology; Bone Metastases; Multiple Myeloma Bone Lesions	Amgen	2012-05-17	PHASE3
NCT01737216	UNKNOWN	Lung Cancer	Hebei Tumor Hospital	2012-11	PHASE2
NCT01907880	COMPLETED	Breast Cancer	Ottawa Hospital Research Institute	2012-08	PHASE4
NCT00844480	TERMINATED	Bone Loss	Thomas J. Schnitzer	2010-03	PHASE2
NCT01788176	UNKNOWN	Complex Regional Pain Syndromes	University of Sao Paulo General Hospital	2013-12	PHASE2
NCT01702415	WITHDRAWN	Cystic Fibrosis	Papworth Hospital NHS Foundation Trust	2013-10	PHASE4
NCT00470223	ACTIVE_NOT_RECRUITING	Sarcoma	UNICANCER	2007-03	PHASE3
NCT02808988	COMPLETED	Chronic Periodontitis	Ondokuz Mayıs University	2013-10	PHASE4
NCT00982124	COMPLETED	Osteogenesis Imperfecta	Shriners Hospitals for Children	2007-10	PHASE3
NCT01348269	COMPLETED	Bone Marrow Edema	Wuerzburg University Hospital	2011-05	PHASE3
NCT00889590	TERMINATED	Giant Cell Tumor of Bone; Osteoclastoma	Leiden University Medical Center	2008-12	PHASE2
NCT01204203	COMPLETED	Mesothelioma	University of Alabama at Birmingham	2009-06	PHASE2
NCT01920568	COMPLETED	Fractures, Bone	GlaxoSmithKline	2013-08	PHASE3
NCT01426555	TERMINATED	Osteoporosis	Antonio Lazzari	2011-02	PHASE2; PHASE3
NCT01732770	COMPLETED	Post Menopausal Osteoporosis	Amgen	2012-11-07	PHASE4
NCT01409811	TERMINATED	Estrogen Receptor-positive Breast Cancer; Invasive Ductal Breast Carcinoma; Progesterone Receptor-positive Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer	City of Hope Medical Center	2012-09-14
NCT02721940	UNKNOWN	Osteonecrosis	Chinese PLA General Hospital	2012-02
NCT01267279	COMPLETED	Osteoporosis	Spokane Joint Replacement Center	2005-01	PHASE4
NCT00329797	COMPLETED	Osteoporosis; Prostate Cancer	Radiation Therapy Oncology Group	2006-03	PHASE3
NCT01671774	COMPLETED	CLDN18.2-positive Gastric Adenocarcinoma; CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction; CLDN18.2-positive Adenocarcinoma of Esophagus	Astellas Pharma Global Development, Inc.	2012-10-16	PHASE1
NCT00556374	COMPLETED	Breast Cancer	Amgen	2006-12-18	PHASE3
NCT00081159	COMPLETED	Metastatic Cancer; Prostate Cancer	M.D. Anderson Cancer Center	2004-07	PHASE2
NCT01404702	TERMINATED	Neuroblastoma	University of Alabama at Birmingham	2011-08	PHASE1
NCT00580047	COMPLETED	Renal Insufficiency	University of Nebraska	2003-12-01
NCT01721993	COMPLETED	Healthy Postmenopausal Women	Thar Pharmaceuticals, Inc	2013-01	PHASE1
NCT00903162	COMPLETED	Breast Cancer	Dana-Farber Cancer Institute	2009-05	PHASE2
NCT00869206	COMPLETED	Breast Adenocarcinoma; DS Stage I Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; Metastatic Malignant Neoplasm to the Bone; Pain; Musculoskeletal Complication; Urinary Complications	Alliance for Clinical Trials in Oncology	2009-03	PHASE3
NCT00375505	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2005-10	PHASE3
NCT00885326	COMPLETED	Neuroblastoma	New Approaches to Neuroblastoma Therapy Consortium	2009-12	PHASE1
NCT00558012	COMPLETED	Osteoporosis; Bone Loss; Fragility Fractures	University of Pittsburgh	2007-12
NCT00685646	COMPLETED	Metastatic Cancer; Prostate Cancer	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	2008-05	PHASE3
NCT01194440	COMPLETED	Ductal Carcinoma in Situ; Estrogen Receptor-positive Breast Cancer; Progesterone Receptor-positive Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2011-02	PHASE2
NCT00781261	UNKNOWN	Osteonecrosis	University of Sydney	2009-08	PHASE2
NCT00333229	TERMINATED	Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women	Novartis Pharmaceuticals	2006-03	PHASE4
NCT00512993	COMPLETED	Breast Cancer	GBG Forschungs GmbH	2004-12	PHASE3
NCT02181101	COMPLETED	Breast Neoplasms	Ludwig-Maximilians - University of Munich	2005-09	PHASE3
NCT00320710	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2006-02	PHASE3
NCT01675089	COMPLETED	Renal Osteodystrophy	University of Sao Paulo General Hospital	2012-07	PHASE4
NCT00691236	UNKNOWN	Osteosarcoma	Tata Memorial Hospital	2008-05	PHASE2; PHASE3
NCT01087008	COMPLETED	Multiple Myeloma	PETHEMA Foundation	2010-04	PHASE4
NCT00972959	COMPLETED	Multiple Myeloma	University of Athens	2009-07	PHASE2
NCT00731016	COMPLETED	Hutchinson-Gilford Progeria Syndrome	Assistance Publique Hopitaux De Marseille	2008-10	PHASE2
NCT00892242	TERMINATED	Adenocarcinoma	Washington University School of Medicine	2009-12	PHASE1
NCT00718861	COMPLETED	Post-menopausal Osteoporosis	Novartis Pharmaceuticals	2008-05	PHASE3
NCT01153425	COMPLETED	Osteoporosis, Osteopenia	University of Pennsylvania	2008-07	PHASE4
NCT00577642	COMPLETED	Multiple Myeloma	Massachusetts General Hospital	2007-10	PHASE2
NCT00326820	UNKNOWN	Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer	Wales Cancer Trials Unit	2006-01	PHASE3
NCT01654367	UNKNOWN	Breast Cancer	Tianjin Medical University	2012-01	PHASE2; PHASE3
NCT00668200	COMPLETED	Paget's Disease of the Bone; Hypocalcemia	Novartis Pharmaceuticals	2008-05	PHASE4
NCT01572545	COMPLETED	Postmenopausal Osteoporosis	Aristotle University Of Thessaloniki	2012-04
NCT00215943	TERMINATED	Multiple Myeloma	H. Lee Moffitt Cancer Center and Research Institute	2003-06	PHASE3
NCT01129336	COMPLETED	First or Second Line HER2-negative Breast Cancer; Metastatic Disease Without Bone Metastasis	Novartis Pharmaceuticals	2010-06	PHASE4
NCT02042872	COMPLETED	Disuse Osteoporosis	James J. Peters Veterans Affairs Medical Center	2006-05	PHASE4
NCT00079001	COMPLETED	Metastatic Cancer; Prostate Cancer	Alliance for Clinical Trials in Oncology	2004-01	PHASE3
NCT01166178	TERMINATED	Osteoporosis; Multiple Sclerosis	Novartis	2010-10	PHASE3
NCT00939900	COMPLETED	Avascular Necrosis of Femoral Head	Seoul National University Bundang Hospital	2009-07	PHASE3
NCT00622505	COMPLETED	Multiple Myeloma	Novartis Pharmaceuticals	2007-11-07	PHASE4
NCT01099436	COMPLETED	Breast Cancer	Borstkanker Onderzoek Groep	2010-04	PHASE3
NCT00742924	COMPLETED	Sarcoma	Children's Oncology Group	2008-08	PHASE1
NCT00365105	COMPLETED	Breast Cancer; Lung Cancer; Metastatic Cancer; Pain; Prostate Cancer	Radiation Therapy Oncology Group	2006-07-11	PHASE3
NCT00242567	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2005-12	PHASE3
NCT00305695	COMPLETED	Hereditary Breast and Ovarian Cancer Syndrome; Osteoporosis; Ovarian Carcinoma	Gynecologic Oncology Group	2005-11-28	PHASE2
NCT01310465	UNKNOWN	Image Changes of Lumbar Fusion; Bone Turnover Markers; Bone Mineral Density	Fudan University	2011-01	PHASE4
NCT00760370	COMPLETED	Multiple Myeloma; Breast Cancer	Vejle Hospital	2008-12	PHASE2
NCT00909961	COMPLETED	Postmenopausal Osteoporosis	Novartis Pharmaceuticals	2009-11	PHASE3
NCT00741377	COMPLETED	Multiple Myeloma Bone Disease	Novartis Pharmaceuticals	2009-01	PHASE1
NCT01016093	UNKNOWN	Beta-Thalassemia; Bone Marrow Transplantation	Tehran University of Medical Sciences	2009-11	PHASE2; PHASE3
NCT00795483	COMPLETED	HIV Infections	Germans Trias i Pujol Hospital	2009-11	PHASE4
NCT00352846	COMPLETED	Non-Hodgkin's Lymphoma; Lymphoma	M.D. Anderson Cancer Center	2006-01	PHASE3
NCT01344967	COMPLETED	Metastatic Breast Cancer With Bone Involvement	University Health Network, Toronto	2009-02	PHASE2; PHASE3
NCT01259193	UNKNOWN	Hepatocellular Carcinoma	Fudan University	2010-10	PHASE2
NCT00432458	COMPLETED	Multiple Myeloma and Plasma Cell Neoplasm	Mayo Clinic	2003-07	PHASE3
NCT00295867	COMPLETED	Breast Cancer	University of California, San Francisco	2004-11-03	PHASE2
NCT00740129	COMPLETED	Paget's Disease of the Bone	Novartis Pharmaceuticals	2008-10-21	PHASE4
NCT00712985	COMPLETED	Breast Cancer	Milton S. Hershey Medical Center	2005-09	PHASE3
NCT01330238	COMPLETED	Low Back Pain	University of Oulu	2008-12	PHASE2
NCT00321932	COMPLETED	Leukemia; Lymphoma; Myelodysplastic Syndromes; Osteoporosis; Ovarian Cancer	University of Minnesota	2005-07	PHASE2
NCT00896532	COMPLETED	Low Bone Mineral Density; Postmenopausal Osteoporosis	Amgen	2009-06-03	PHASE2
NCT00301873	COMPLETED	Brain Tumors; Osteoporosis; Central Nervous System(CNS)Malignancies	Duke University	2006-05	PHASE2
NCT00774020	COMPLETED	Paget's Disease of Bone	Novartis Pharmaceuticals	2008-10-30	PHASE4
NCT00375752	TERMINATED	Breast Neoplasms	Novartis Pharmaceuticals	2006-06-01	PHASE4
NCT00912938	UNKNOWN	Metastatic Breast Cancer	Korean Breast Cancer Study Group	2007-12	PHASE4
NCT00391690	COMPLETED	Prostate Cancer	Novartis	2006-02	PHASE4
NCT01218035	COMPLETED	Hip Osteoarthritis	Turku University Hospital	2007-05	PHASE4
NCT00171314	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2004-03	PHASE3
NCT00376740	COMPLETED	Breast Cancer	Soroka University Medical Center	2005-09	PHASE3
NCT00927186	COMPLETED	Osteoporosis, Post-menopausal	Eli Lilly and Company	2009-07	PHASE4
NCT00439647	COMPLETED	Male Osteoporosis	Novartis Pharmaceuticals	2006-12	PHASE3
NCT01004510	TERMINATED	Malignant Pleural Effusion; Non Small Cell Lung Cancer	Peter Bushunow MD	2009-11	PHASE2
NCT00332709	COMPLETED	Osteoporosis; Postmenopausal	Novartis	2006-01	PHASE3
NCT00745485	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2008-08	PHASE4
NCT00172042	COMPLETED	Non-Small-Cell Lung Cancer	Novartis Pharmaceuticals	2005-03	PHASE3
NCT00297830	COMPLETED	Heart Transplantation; Liver Transplantation; Bone Resorption	Columbia University	2005-11	PHASE2; PHASE3
NCT00966992	TERMINATED	Uterine Cervical Neoplasms	Washington University School of Medicine	2009-08	PHASE2
NCT00171340	COMPLETED	Bone Loss; Breast Cancer	Novartis Pharmaceuticals	2003-05	PHASE3
NCT00375427	COMPLETED	Breast Cancer With Bone Metastasis	Novartis Pharmaceuticals	2006-02	PHASE3
NCT00558272	COMPLETED	Breast Cancer; Prostate Cancer; Bone Neoplasms	AstraZeneca	2008-02	PHASE2
NCT00525759	COMPLETED	Breast Cancer	Sheffield Teaching Hospitals NHS Foundation Trust	2007-07	PHASE2
NCT00145327	COMPLETED	Osteoporosis	Novartis	2005-05	PHASE3
NCT00424983	COMPLETED	Multiple Myeloma; Breast Cancer	Novartis Pharmaceuticals	2006-11	PHASE1
NCT00321620	COMPLETED	Bone Metastases	Amgen	2006-04-01	PHASE3
NCT00807963	COMPLETED	Risk Factors for or a Diagnosis of Osteoporosis	Halozyme Therapeutics	2008-12	PHASE1
NCT00434447	COMPLETED	Bone Neoplasms	Novartis Pharmaceuticals	2006-12	PHASE4
NCT00219271	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2003-09	PHASE4
NCT00265200	TERMINATED	Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung; Metastases	University of Louisville	2005-02	PHASE2
NCT00321464	COMPLETED	Bone Metastases	Amgen	2006-04-01	PHASE3
NCT00334139	COMPLETED	Prostate Cancer; Breast Cancer; Bone Metastasis	Novartis Pharmaceuticals	2006-05	PHASE4
NCT00172055	COMPLETED	Cancer Prostate	Novartis Pharmaceuticals	2004-12	PHASE3
NCT00172003	COMPLETED	Renal Cell Cancer; Neoplasm Metastasis	Novartis Pharmaceuticals	2004-09	PHASE4
NCT00477217	WITHDRAWN	Osteonecrosis	Novartis	2008-01	PHASE2
NCT00330759	COMPLETED	Bone Metastases	Amgen	2006-06-01	PHASE3
NCT00879034	COMPLETED	Progeria; Hutchinson-Gilford Syndrome	Boston Children's Hospital	2009-03	PHASE2
NCT00258258	TERMINATED	Multiple Myeloma and Plasma Cell Neoplasm	Roswell Park Cancer Institute	2005-08	PHASE1
NCT00588913	COMPLETED	Kidney Cancer; Metastatic Cancer	Tokyo Women's Medical University	2006-01	PHASE1; PHASE2
NCT00439244	COMPLETED	Osteoporosis	Novartis	2006-12	PHASE3
NCT00636740	COMPLETED	Hormone-Refractory Prostate Cancer	Merrion Pharmaceuticals, LLC	2008-02	PHASE2
NCT00050011	COMPLETED	Breast Neoplasms; Osteoporosis	Novartis Pharmaceuticals	2002-09	PHASE3
NCT00697619	COMPLETED	Nasopharyngeal Cancer	Sun Yat-sen University	2005-09	PHASE2
NCT00415779	COMPLETED	Metastatic Prostate Cancer	National Cancer Institute, Naples	2006-07	PHASE1
NCT00554918	COMPLETED	Metastatic Cancer; Prostate Cancer	University Hospital Birmingham	2005-02	PHASE2
NCT00404820	COMPLETED	Osteoporosis	Novartis	2006-10	PHASE3
NCT00171964	COMPLETED	Pain; Neoplasm Metastasis; Cancer	Novartis Pharmaceuticals	2002-05	PHASE4
NCT00058188	TERMINATED	Osteoporosis; Prostate Cancer	Northwestern University	2003-03	PHASE3
NCT00171925	TERMINATED	Multiple Myeloma Stage I	Novartis Pharmaceuticals	2000-08	PHASE3
NCT00172068	TERMINATED	Primary Breast Cancer	Novartis Pharmaceuticals	2002-01	PHASE2
NCT00263484	COMPLETED	Multiple Myeloma	Gleneagles Hospital	2005-12	PHASE2
NCT00582790	TERMINATED	Kidney Cancer	University of Wisconsin, Madison	2003-08	PHASE2
NCT00524849	COMPLETED	Metastatic Breast Cancer; Bone Metastases	Fudan University	2006-11	PHASE2; PHASE3
NCT00278434	TERMINATED	Cervical Cancer; Precancerous Condition	University of California, San Francisco	2005-04	PHASE1
NCT00431444	COMPLETED	Osteoporosis	Novartis	2007-01	PHASE4
NCT00436917	COMPLETED	Breast Cancer; Osteoporosis	Mayo Clinic	2006-04
NCT00639392	WITHDRAWN	Sickle Cell Disease	Virginia Commonwealth University	2007-06	PHASE1; PHASE2
NCT00206388	COMPLETED	NEUROBLASTOMA	Baylor College of Medicine	2005-04	PHASE1
NCT00361595	COMPLETED	Osteoporosis	The Cleveland Clinic	2006-08
NCT00434317	COMPLETED	Neoplasm Metastasis	Novartis	2005-08	PHASE4
NCT00295646	COMPLETED	Breast Cancer	Austrian Breast & Colorectal Cancer Study Group	1999-06	PHASE3
NCT00237146	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2003-11	PHASE4
NCT00287261	COMPLETED	Myelofibrosis; Myeloid Metaplasia	Universitaire Ziekenhuizen KU Leuven	2006-02	PHASE2
NCT00132808	COMPLETED	Osteopenia	Novartis Pharmaceuticals	2004-07	PHASE3
NCT00099177	TERMINATED	Pain; Bone Neoplasm; Neoplasm Metastasis	Hoffmann-La Roche	2005-08	PHASE3
NCT00099203	TERMINATED	Pain; Bone Neoplasm; Neoplasm Metastasis	Hoffmann-La Roche	2005-07	PHASE3
NCT00489424	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2007-06	PHASE4
NCT00226954	TERMINATED	Urologic Neoplasms	Stanford University	2003-03	PHASE2
NCT01341262	COMPLETED	Multiple Myeloma	IRCCS Azienda Ospedaliero-Universitaria di Bologna	2002-03	PHASE2
NCT00086268	COMPLETED	Non Small Cell Lung Carcinoma	Novartis Pharmaceuticals	2004-04	PHASE3
NCT00104104	COMPLETED	Multiple Myeloma	Novartis Pharmaceuticals	2004-10	PHASE4
NCT00210119	TERMINATED	Myeloid Leukemia, Chronic	Institut Bergonié	2006-07-12	PHASE2
NCT00798473	COMPLETED	Crohn's Disease; Osteopenia; Osteoporosis	McGill University Health Centre/Research Institute of the McGill University Health Centre	2004-09	PHASE3
NCT00202059	COMPLETED	Breast Cancer	HealthPartners Institute	2003-06	PHASE3
NCT00097825	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2004-04	PHASE3
NCT00242554	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2002-10	PHASE4
NCT00375648	COMPLETED	Pain	Novartis Pharmaceuticals	2005-06	PHASE3
NCT00482378	COMPLETED	Multiple Myeloma and Plasma Cell Neoplasm; Pain	Mayo Clinic	2005-03-21	PHASE1; PHASE2
NCT00131118	COMPLETED	Osteogenesis Imperfecta	Novartis Pharmaceuticals	2004-07	PHASE2
NCT00391950	TERMINATED	Prostate Cancer	Novartis	2006-10	PHASE3
NCT00063479	COMPLETED	Osteogenesis Imperfecta	Novartis Pharmaceuticals	2003-06	PHASE2
NCT00072930	COMPLETED	Prostate Cancer	MedImmune LLC	2003-12	PHASE2
NCT00100620	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2004-06	PHASE3
NCT00107263	COMPLETED	Breast Cancer; Osteoporosis	Alliance for Clinical Trials in Oncology	2005-01	PHASE3
NCT00171639	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2004-06	PHASE3
NCT00247650	COMPLETED	Breast Cancer	Novartis	2005-09	PHASE2
NCT00216151	TERMINATED	Multiple Myeloma	Hoosier Cancer Research Network	2005-06	PHASE2
NCT00022087	COMPLETED	Breast Cancer; Osteoporosis	Alliance for Clinical Trials in Oncology	2001-12	PHASE3
NCT00046254	COMPLETED	Osteoporosis; Hip Fracture	Novartis Pharmaceuticals	2002-02	PHASE3
NCT00181558	COMPLETED	Prostate Cancer; Adenocarcinoma of the Prostate	Massachusetts General Hospital	2001-12	PHASE2
NCT00130494	TERMINATED	Breast Cancer; Neoplasm Metastasis	Spanish Breast Cancer Research Group	2002-08-29	PHASE3
NCT00258765	TERMINATED	Prostate Cancer	Novartis Pharmaceuticals	2006-05	PHASE2
NCT00049829	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2002-01	PHASE3
NCT00033332	COMPLETED	Multiple Myeloma and Plasma Cell Neoplasm	National Cancer Institute (NCI)	2002-04	PHASE3
NCT00346242	COMPLETED	Thalassemia	Novartis Pharmaceuticals	2004-03	PHASE4
NCT00181584	COMPLETED	Bone Loss; Prostate Cancer	Massachusetts General Hospital	2003-09	PHASE2
NCT00241111	COMPLETED	Prostate Cancer With Bone Metastasis	Novartis Pharmaceuticals	2003-09	PHASE4
NCT00237159	COMPLETED	Prostate Cancer Patients With Bone Metastasis	Novartis Pharmaceuticals	2002-10	PHASE4
NCT00164008	COMPLETED	Osteopenia; Complications of Heart-lung Transplant; Other Complications of Lung Transplant	Bayside Health	2002-10	PHASE4
NCT00097812	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2004-05	PHASE3
NCT00145275	COMPLETED	Osteopenia	Novartis	2004-12	PHASE3
NCT00172029	COMPLETED	Breast Cancer With Metastatic Bone Disease	Novartis	2003-04	PHASE4
NCT00151073	COMPLETED	Hormone-Refractory Prostate Cancer	University of Michigan Rogel Cancer Center	2002-04	PHASE2
NCT00100555	COMPLETED	Osteoporosis	Novartis Pharmaceuticals	2004-06	PHASE3
NCT00172016	COMPLETED	Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated	Novartis Pharmaceuticals	2004-01	PHASE4
NCT00039104	COMPLETED	Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer	National Cancer Institute (NCI)	2002-04	PHASE2
NCT00004928	COMPLETED	Prostate Cancer	Memorial Sloan Kettering Cancer Center	1999-10	PHASE1
NCT00060138	COMPLETED	Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer; Pain	Chugai Pharmaceutical	2002-11	PHASE1; PHASE2
NCT00051636	COMPLETED	Paget's Disease of Bone	Novartis Pharmaceuticals	2001-01	PHASE3
NCT00035997	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2002-04	PHASE4
NCT00103740	COMPLETED	Paget's Disease of Bone	Novartis Pharmaceuticals	2002-04	PHASE3
NCT00005073	TERMINATED	Prostate Cancer	Novartis Pharmaceuticals	1999-09	PHASE3
NCT00029224	COMPLETED	Breast Cancer; Multiple Myeloma; Prostate Cancer	Novartis	2001-10	PHASE4
NCT00003884	COMPLETED	Hypercalcemia of Malignancy; Lung Cancer; Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific	Novartis	1998-08	PHASE3
NCT00051779	COMPLETED	Breast Neoplasms; Breast Cancer; Metastasis	Chugai Pharma USA		PHASE1
NCT00049452	COMPLETED	Breast Cancer; Osteoporosis	Herbert Irving Comprehensive Cancer Center	2001-12	PHASE3
NCT00372710	TERMINATED	Breast Cancer With Bone Metastasis	Novartis	2002-08	PHASE3
NCT00264420	COMPLETED	Bone Metastases; Breast Cancer; Lung Cancer; Prostate Cancer	The Cleveland Clinic	2005-12	PHASE1
NCT00114556	COMPLETED	Osteoporosis; Liver Transplantation; Fractures	Royal Prince Alfred Hospital, Sydney, Australia	2000-02	PHASE4
NCT00072020	UNKNOWN	Breast Cancer; Metastatic Cancer	University of Sheffield	2003-08	PHASE3
NCT00126386	COMPLETED	Cancer; Hypercalcemia; Pain	Alberta Health services	2004-01
NCT00099541	COMPLETED	Non-Small-Cell Lung Cancer; Pleural Effusion, Malignant	Novartis Pharmaceuticals	2004-11	PHASE4
NCT00219219	COMPLETED	Prostate Cancer	Novartis	2003-09	PHASE4
NCT00520052	COMPLETED	Osteoporosis	Wirral University Teaching Hospital NHS Trust	2003-08
NCT00458796	TERMINATED	Breast Cancer; Hypercalcemia of Malignancy; Metastatic Cancer; Musculoskeletal Complications; Pain	University of Leeds	2006-03
NCT00114270	COMPLETED	Breast Cancer; Osteoporosis	University of Virginia	2004-05
NCT00219258	COMPLETED	Treatment of Bone Metastases	Novartis	2005-07	PHASE3
NCT00489905	COMPLETED	Prostatic Neoplasms; Bone Density	Hospital Authority, Hong Kong	2005-04
NCT00242528	WITHDRAWN	Multiple Myeloma	Novartis	2004-04	PHASE4
NCT00120133	COMPLETED	Osteoporosis	Children's Mercy Hospital Kansas City	2004-12
NCT00087659	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2003-12
NCT00063609	COMPLETED	Prostate Cancer	Novartis Pharmaceuticals	2003-04	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-04-20)

Check the Zoledronic acid monohydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zoledronic acid monohydrate selectively binds to bone mineral and inhibits key mevalonate pathway enzymes, preventing the isoprenylation of small GTP-binding proteins such as Ras and Rho to induce osteoclast apoptosis. By blocking osteoclast-mediated bone resorption, this mechanism maintains skeletal density and reduces skeletal-related events in clinical conditions such as postmenopausal osteoporosis and bone metastases.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).