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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
C5H10N2O7P2
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

The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients

Phase 4
Completed
Conditions
Osteoporosis
Liver Transplantation
Fractures
First Posted Date
2005-06-16
Last Posted Date
2006-05-09
Lead Sponsor
Royal Prince Alfred Hospital, Sydney, Australia
Target Recruit Count
100
Registration Number
NCT00114556
Locations
🇦🇺

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

Not Applicable
Completed
Conditions
Breast Cancer
Osteoporosis
First Posted Date
2005-06-14
Last Posted Date
2013-03-26
Lead Sponsor
University of Virginia
Registration Number
NCT00114270
Locations
🇺🇸

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Zoledronate in Preventing Bone Loss in Postmenopausal Women Who Are Receiving Letrozole for Stage I, Stage II, or Stage IIIA Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Osteoporosis
Interventions
First Posted Date
2005-04-06
Last Posted Date
2016-12-06
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
558
Registration Number
NCT00107263

A Multiple Myeloma Trial in Patients With Bone Metastases

Phase 4
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2005-02-23
Last Posted Date
2011-06-29
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
179
Registration Number
NCT00104104
Locations
🇺🇸

Osceola Cancer Center, Kissimmee, Florida, United States

🇺🇸

Maryland Oncology-Hematology PA, Columbia, Maryland, United States

🇺🇸

Fox Valley Hematology Oncology SC, Appleton, Wisconsin, United States

and more 65 locations

Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

Phase 3
Completed
Conditions
Paget's Disease of Bone
Interventions
First Posted Date
2005-02-15
Last Posted Date
2012-06-04
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
185
Registration Number
NCT00103740
Locations
🇬🇧

Novartis Investigative site, Oxford, United Kingdom

🇬🇧

Novartis Investigative Site, London, United Kingdom

Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density

Phase 2
Conditions
HIV Infections
Osteopenia
Osteoporosis
Interventions
First Posted Date
2005-02-07
Last Posted Date
2008-09-26
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
30
Registration Number
NCT00102908
Locations
🇺🇸

University of California, San Diego, San Diego, California, United States

Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

Phase 3
Completed
Conditions
Osteoporosis
First Posted Date
2005-01-04
Last Posted Date
2017-05-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
802
Registration Number
NCT00100620
Locations
🇺🇸

McGuire VA Medical Center, Richmond, Virginia, United States

🇺🇸

United Osteoporosis Centers, Gainesville, Georgia, United States

🇺🇸

Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders, Birmingham, Alabama, United States

and more 3 locations

A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

Phase 3
Completed
Conditions
Osteoporosis
First Posted Date
2005-01-04
Last Posted Date
2012-04-27
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
120
Registration Number
NCT00100555
Locations
🇺🇸

St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education, Houston, Texas, United States

🇺🇸

Univ. of Alabama/Division of Clinical Immunology and Rheumatology, Birmingham, Alabama, United States

🇺🇸

Denver Arthritis Clinic, Denver, Colorado, United States

and more 14 locations

Non-small Cell Lung Cancer Registry

Phase 4
Completed
Conditions
Non-Small-Cell Lung Cancer
Pleural Effusion, Malignant
First Posted Date
2004-12-16
Last Posted Date
2009-11-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
300
Registration Number
NCT00099541
Locations
🇺🇸

Hembree Cancer Center-St. Edward Mercy Medical Center, Fort Smith, Arkansas, United States

🇺🇸

Gainesville Hematology Oncology Associates, Gainesville, Florida, United States

🇺🇸

Center for Cancer Care & Research, Lakeland, Florida, United States

and more 98 locations

A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Phase 3
Terminated
Conditions
Bone Neoplasm
Neoplasm Metastasis
Pain
Interventions
First Posted Date
2004-12-10
Last Posted Date
2017-08-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
96
Registration Number
NCT00099177
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