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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

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
Drug: Placebo to Zoledronic Acid
Dietary Supplement: Calcium and Vitamin D
First Posted Date
2003-01-15
Last Posted Date
2012-05-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
172
Registration Number
NCT00051636
Locations
🇬🇧

Novartis Investigative Site, Vale of Glamorgan, United Kingdom

🇬🇧

Novartis investigative site, Pernarth, United Kingdom

🇬🇧

Novartis Investigative site, Penarth, United Kingdom

Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy

Phase 3
Completed
Conditions
Breast Neoplasms
Osteoporosis
Interventions
First Posted Date
2002-11-20
Last Posted Date
2014-03-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
602
Registration Number
NCT00050011
Locations
🇺🇸

FL Community Cancer Center, Brooksville, Florida, United States

🇺🇸

Eastern Connecticut Hematology/Oncology Associates, Norwich, Connecticut, United States

🇺🇸

Elmhurst Memorial Hospital, Elhurst, Illinois, United States

and more 41 locations

HORIZON-PFT: Pivotal Fracture Trial

Phase 3
Completed
Conditions
Osteoporosis
First Posted Date
2002-11-15
Last Posted Date
2011-11-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
7700
Registration Number
NCT00049829
Locations
🇺🇸

Palm Beach Research Center, West Palm Beach, Florida, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 56 locations

Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

Phase 3
Completed
Conditions
Osteoporosis
Hip Fracture
First Posted Date
2002-09-25
Last Posted Date
2012-05-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
2127
Registration Number
NCT00046254
Locations
🇩🇪

Novartis, Nuernberg, Germany

🇺🇸

Radiant Research Lake Worth, Lake Worth, Florida, United States

🇺🇸

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

and more 25 locations

Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Phase 4
Completed
Conditions
Prostate Cancer
First Posted Date
2002-05-08
Last Posted Date
2009-11-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
261
Registration Number
NCT00035997
Locations
🇺🇸

Urology Associates of Central CA, Fresno, California, United States

🇺🇸

Advanced Urology Medical Office, Los Angeles, California, United States

🇺🇸

Southwest Florida Urologic Association, Fort Myers, Florida, United States

and more 53 locations

Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

Phase 4
Completed
Conditions
Breast Cancer
Multiple Myeloma
Prostate Cancer
First Posted Date
2002-01-10
Last Posted Date
2012-02-01
Lead Sponsor
Novartis
Target Recruit Count
500
Registration Number
NCT00029224
Locations
🇺🇸

Osceola Cancer Center, Kissimmee, Florida, United States

🇺🇸

Stockton Hematology Oncology Medical Group, Stockton, California, United States

🇺🇸

Hematology-Oncology Associates PC, Albuquerque, New Mexico, United States

and more 4 locations
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