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

A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

Phase 3

Terminated

Conditions: Pain
Neoplasm Metastasis
Bone Neoplasm

Interventions: Drug: ibandronate [Bondronat]
Drug: zoledronic acid

First Posted Date: 2004-12-10

Last Posted Date: 2017-08-16

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 163

Registration Number: NCT00099203

Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

Phase 3

Completed

Conditions: Osteoporosis

First Posted Date: 2004-12-01

Last Posted Date: 2012-04-27

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 288

Registration Number: NCT00097825

Locations: 🇺🇸
St. Joseph Hospital, Bangor, Maine, United States
🇺🇸
Osteoporosis and Clinical Trials Center, Hagerstown, Maryland, United States
🇺🇸
UC Bone Health and Osteoporosis Center, Cincinnati, Ohio, United States

and more 22 locations

Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Phase 3

Completed

Conditions: Osteoporosis

First Posted Date: 2004-12-01

Last Posted Date: 2012-04-27

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 220

Registration Number: NCT00097812

Locations: 🇺🇸
Arthritis Center of Nebraska, Lincoln, Nebraska, United States
🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇩🇪
Novartis, Nuernberg, Germany

and more 9 locations

Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone

Phase 3

Completed

Conditions: Hypercalcemia of Malignancy
Lung Cancer
Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2004-07-22

Last Posted Date: 2013-02-21

Lead Sponsor: Novartis

Target Recruit Count: 600

Registration Number: NCT00003884

Locations: 🇺🇸
Cancer Specialist of South Texas. P.A., Corpus Christi, Texas, United States
🇺🇸
New England Medical Center Hospital, Boston, Massachusetts, United States
🇺🇸
American Medical Research Institute, Inc., Atlanta, Georgia, United States

and more 52 locations

A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

Not Applicable

Completed

Conditions: Prostate Cancer

First Posted Date: 2004-07-14

Last Posted Date: 2009-11-23

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT00087659

Locations: 🇺🇸
Veterans Affairs Medical Center, Augusta, Georgia, United States
🇺🇸
WJB Dorn Veteran Affairs Medical Center, Columbia, South Carolina, United States
🇺🇸
West Sde Vamc, Chicago, Illinois, United States

and more 12 locations

Non-small Cell Lung Cancer Study US75 (Z-PACT)

Phase 3

Completed

Conditions: Non Small Cell Lung Carcinoma

Interventions: Drug: zoledronic acid
Drug: Taxotere
Drug: Carboplatin

First Posted Date: 2004-07-01

Last Posted Date: 2017-09-13

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 250

Registration Number: NCT00086268

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Advocate Illinois Masonic Medical Center Creticos Cancer Center, Chicago, Illinois, United States
🇺🇸
Central Indiana Cancer Centers, Indianapolis, Indiana, United States

and more 76 locations

Zoledronate Plus Standard Therapy Compared With Placebo Plus Standard Therapy to Prevent Bone Metastases in Patients With Recurrent Prostate Cancer That Has No Symptoms

Phase 3

Terminated

Conditions: Prostate Cancer

First Posted Date: 2004-06-18

Last Posted Date: 2013-05-01

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 544

Registration Number: NCT00005073

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Pamidronate
Drug: Thalidomide
Drug: Zometa

First Posted Date: 2004-05-24

Last Posted Date: 2015-06-24

Lead Sponsor: University of Arkansas

Target Recruit Count: 83

Registration Number: NCT00083382

Locations: 🇺🇸
University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas, United States

Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases

Phase 2

Completed

Conditions: Metastatic Cancer
Prostate Cancer

Interventions: Drug: Doxorubicin hydrochloride
Drug: Goserelin acetate
Drug: Leuprolide acetate
Drug: Zoledronic acid
Procedure: orchiectomy
Radiation: strontium chloride Sr

First Posted Date: 2004-04-08

Last Posted Date: 2016-11-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 80

Registration Number: NCT00081159

Locations: 🇺🇸
M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States
🇺🇸
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
🇺🇸
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States

and more 1 locations

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

Phase 3

Completed

Conditions: Metastatic Cancer
Prostate Cancer

Interventions: Drug: zoledronic acid
Other: placebo
Drug: androgen deprivation therapy
Drug: GnRH agonist
Dietary Supplement: Calcium supplement
Dietary Supplement: Vitamin D

First Posted Date: 2004-03-09

Last Posted Date: 2020-05-12

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 645

Registration Number: NCT00079001

Locations: 🇺🇸
Good Samaritan Hospital of Maryland, Baltimore, Maryland, United States
🇺🇸
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
🇺🇸
Fisher-Titus Medical Center, Norwalk, Ohio, United States

and more 237 locations

Drug Development Updates

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