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 BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients

Phase 1

Completed

Conditions: Multiple Myeloma Bone Disease

Interventions: Drug: BHQ880
Drug: Zoledronic acid

First Posted Date: 2008-08-26

Last Posted Date: 2013-02-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 28

Registration Number: NCT00741377

Locations: 🇺🇸
Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, United States
🇺🇸
MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (11), Houston, Texas, United States
🇺🇸
Mayo Clinic - Arizona Cancer Clinical Research Unit, Scottsdale, Arizona, United States

and more 3 locations

Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

Phase 4

Completed

Conditions: Paget's Disease of the Bone

Interventions: Drug: Zoledronic Acid

First Posted Date: 2008-08-22

Last Posted Date: 2021-05-26

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 6

Registration Number: NCT00740129

Locations: 🇬🇧
Novartis Investigative site, Oxford, United Kingdom

3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

Phase 3

Completed

Conditions: Post-menopausal Osteoporosis

Interventions: Drug: Placebo
Drug: Zoledronic acid

First Posted Date: 2008-07-21

Last Posted Date: 2014-10-09

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 190

Registration Number: NCT00718861

Locations: 🇹🇭
Novartis Investigative Site, Khonkaen, Thailand

Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

Phase 2

Conditions: Osteosarcoma

Interventions: Drug: Standard chemotherapy
Drug: Zoledronic acid

First Posted Date: 2008-06-05

Last Posted Date: 2011-06-23

Lead Sponsor: Tata Memorial Hospital

Target Recruit Count: 60

Registration Number: NCT00691236

Locations: 🇮🇳
Tata Memorial Hospital, Mumbai, Maharashtra, India

Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases

Phase 3

Completed

Conditions: Metastatic Cancer
Prostate Cancer

Interventions: Drug: antiandrogen therapy
Drug: zoledronic acid

First Posted Date: 2008-05-28

Last Posted Date: 2015-10-16

Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Target Recruit Count: 227

Registration Number: NCT00685646

Locations: 🇯🇵
Kyoto University Hospital, Kyoto, Japan

Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

Phase 1

Withdrawn

Conditions: Sickle Cell Disease

Interventions: Drug: Placebo
Drug: Zoledronic Acid

First Posted Date: 2008-03-20

Last Posted Date: 2011-11-11

Lead Sponsor: Virginia Commonwealth University

Registration Number: NCT00639392

Locations: 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

Phase 2

Completed

Conditions: Hormone-Refractory Prostate Cancer

Interventions: Drug: Zoledronic Acid 20mg Tablets
Drug: Zoledronic Acid

First Posted Date: 2008-03-14

Last Posted Date: 2009-02-20

Lead Sponsor: Merrion Pharmaceuticals, LLC

Target Recruit Count: 30

Registration Number: NCT00636740

Locations: 🇺🇸
Birmingham Hematology & Oncology Associates, LLC, Birmingham, Alabama, United States
🇺🇸
Cancer Care of North Florida, P.A., Lake City, Florida, United States
🇺🇸
Lakeland Regional Cancer Center, Lakeland, Florida, United States

and more 10 locations

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants

Phase 4

Completed

Conditions: Multiple Myeloma

Interventions: Drug: zoledronic acid

First Posted Date: 2008-02-25

Last Posted Date: 2021-05-26

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 121

Registration Number: NCT00622505

Locations: 🇺🇸
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr, Maywood, Illinois, United States
🇺🇸
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
Dana Farber Cancer Institute Clinical Research Coordinator, Boston, Massachusetts, United States

and more 39 locations