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

Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year

Phase 1
Completed
Conditions
Interventions
First Posted Date
2007-01-22
Last Posted Date
2020-12-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT00424983
Locations
🇺🇸

Oncotherapeutics, West Hollywood, California, United States

🇺🇸

Rocky Mountain Cancer Centers RMCC, Greenwood Village, Colorado, United States

🇺🇸

Norwalk Hospital, Norwalk, Connecticut, United States

and more 4 locations

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

Phase 1
Completed
Conditions
First Posted Date
2006-12-25
Last Posted Date
2010-02-24
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
36
Registration Number
NCT00415779
Locations
🇮🇹

Istituto Nazionale dei Tumori, Napoli, Italy

🇮🇹

Ospedale Oncologico Regionale C.R.O.B. - Basilicata, Rionero in Vulture, Italy

HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

First Posted Date
2006-12-15
Last Posted Date
2023-03-24
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
1294
Registration Number
NCT00412022
Locations
🇮🇹

Istituto Nazionale per la ricerca Sul Cancro, Genova, Italy

🇮🇹

Ospedale Santa Chiara, Trento, Italy

🇮🇹

Ospedale Unico della Versilia, Lucca, Italy

and more 16 locations

Maintaining Bone Strength in Men With Prostate Cancer

Phase 3
Terminated
Conditions
First Posted Date
2006-10-25
Last Posted Date
2009-11-23
Lead Sponsor
Novartis
Target Recruit Count
300
Registration Number
NCT00391950

Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer

Phase 4
Completed
Conditions
First Posted Date
2006-10-24
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
99
Registration Number
NCT00391690
Locations
🇩🇪

Novartis Investigative Site, Tuebingen, Germany

Effectiveness of Zoledronic Acid in the Prevention of Osteoporosis in Early Breast Cancer Patients Receiving Letrozole

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-09-15
Last Posted Date
2011-08-23
Lead Sponsor
Soroka University Medical Center
Target Recruit Count
90
Registration Number
NCT00376740
Locations
🇮🇱

Soroka University Medical Center, Beer Sheva, Israel

🇮🇱

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-09-13
Last Posted Date
2015-09-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
70
Registration Number
NCT00375505
Locations
🇩🇪

Novartis Investigative Site, Marburg, Germany

Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-09-13
Last Posted Date
2017-06-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
61
Registration Number
NCT00375648
Locations
🇫🇷

Novartis Investigative Site, Monpellier, France

Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-09-13
Last Posted Date
2012-04-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
430
Registration Number
NCT00375427
Locations
🇮🇹

Novartis Investigative Site, Forlì, Italy

Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions

Phase 3
Terminated
Conditions
First Posted Date
2006-09-07
Last Posted Date
2009-11-23
Lead Sponsor
Novartis
Target Recruit Count
30
Registration Number
NCT00372710
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