Zoledronic acid

Generic Name: Zoledronic acid

Brand Names: Aclasta, Reclast, Zometa, Zoledronic Acid Accord, Zoledronic acid Actavis, Zoledronic acid medac, Zoledronic acid Teva, Zoledronic Acid Hospira, Zoledronic acid Mylan

Drug Type: Small Molecule

Chemical Formula: C_₅H_₁₀N_₂O_₇P_₂

CAS Number: 118072-93-8

Unique Ingredient Identifier: 70HZ18PH24

Background: Zoledronic acid, or CGP 42'446, is a third generation, nitrogen containing bisphosphonate similar to ibandronic acid, minodronic acid, and risedronic acid. Zoledronic acid is used to treat and prevent multiple forms of osteoporosis, hypercalcemia of malignancy, multiple myeloma, bone metastases from solid tumors, and Paget’s disease of bone. Zoledronic acid was first described in the literature in 1994.

Zoledronic acid was granted FDA approval on 20 August 2001.

Indication: Zoledronic acid is indicated to treat hypercalcemia of malignancy, multiple myeloma, bone metastases from solid tumors, osteoporosis in men and postmenopausal women, glucocorticoid induced osteoporosis, and Paget's disease of bone in men and women. Zoledronic acid is also indicated for the prevention of osteoporosis in post menopausal women and glucocorticoid induced osteoporosis.

Associated Conditions: Bone Metastases, Hypercalcemia of Malignancy, Multiple Myeloma (MM), Osteoporosis, Osteoporosis caused by Glucocorticoid Treatment, Paget's Disease of Bone, Paget’s Disease

Associated Therapies: Bone Mineral Density

Clinical Trials

Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer

Phase 2

Completed

Conditions: Breast Neoplasms

Interventions: Drug: Zometa
Drug: Epirubicin
Drug: Docetaxel
Drug: Trastuzumab
Radiation: External beam radiation
Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection

First Posted Date: 2005-10-19

Last Posted Date: 2013-08-13

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 120

Registration Number: NCT00242203

Locations: 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States

Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Phase 4

Completed

Conditions: Prostate Cancer With Bone Metastasis

Interventions: Drug: zoledronic acid

First Posted Date: 2005-10-18

Last Posted Date: 2017-03-06

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 148

Registration Number: NCT00241111

Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

Phase 4

Completed

Conditions: Prostate Cancer Patients With Bone Metastasis

Interventions: Drug: Zoledronic acid

First Posted Date: 2005-10-12

Last Posted Date: 2011-03-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 284

Registration Number: NCT00237159

Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy

Phase 4

Completed

Conditions: Prostate Cancer

Interventions: Drug: Zoledronic acid

First Posted Date: 2005-10-12

Last Posted Date: 2017-02-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 38

Registration Number: NCT00237146

Locations: 🇻🇪
Novartis Investigative Site, Caracas, Venezuela

Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer

Phase 2

Terminated

Conditions: Urologic Neoplasms

Interventions: Drug: zoledronic acid

First Posted Date: 2005-09-27

Last Posted Date: 2020-03-18

Lead Sponsor: Stanford University

Target Recruit Count: 23

Registration Number: NCT00226954

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)

Phase 3

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: zoledronic acid
Drug: vincristine
Drug: dexamethasone
Drug: adriamycin
Drug: thalidomide

First Posted Date: 2005-09-22

Last Posted Date: 2014-04-17

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 90

Registration Number: NCT00215943

Locations: 🇺🇸
Morton Plant Hospital, Clearwater, Florida, United States
🇺🇸
Fawcett Memorial Hospital, Port Charlotte, Florida, United States
🇺🇸
Watson Clinic, Lakeland, Florida, United States

and more 2 locations

Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

Phase 4

Completed

Conditions: Prostate Cancer

Interventions: Drug: Zoledronic acid

First Posted Date: 2005-09-22

Last Posted Date: 2017-05-31

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 60

Registration Number: NCT00219271

Locations: 🇬🇷
Novartis Investigative Site, Athens, Greece

Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Zoledronic Acid

First Posted Date: 2005-09-22

Last Posted Date: 2011-05-02

Lead Sponsor: Hoosier Cancer Research Network

Target Recruit Count: 3

Registration Number: NCT00216151

Locations: 🇺🇸
Elkhart Clinic, Elkhart, Indiana, United States
🇺🇸
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
🇺🇸
Oncology Hematology Associates of SW Indiana, Evansville, Indiana, United States

and more 5 locations