MedPath

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

Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2005-09-21
Last Posted Date
2019-11-27
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
68
Registration Number
NCT00213980
Locations
🇺🇸

University of Wisconsin, Madison, Wisconsin, United States

Effects of Zometa and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
First Posted Date
2005-09-20
Last Posted Date
2015-12-16
Lead Sponsor
HealthPartners Institute
Target Recruit Count
72
Registration Number
NCT00202059
Locations
🇺🇸

Park Nicollet Institute, St. Louis Park, Minnesota, United States

RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
Drug: Leuprorelin Acetate
Radiation: Conventional external beam therapy
Drug: Zoledronic Acid
First Posted Date
2005-09-19
Last Posted Date
2017-10-12
Lead Sponsor
Trans Tasman Radiation Oncology Group
Target Recruit Count
1071
Registration Number
NCT00193856
Locations
🇦🇺

Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia

🇦🇺

Royal North Shore Hospital, Sydney, New South Wales, Australia

🇦🇺

St George Hospital, Kogarah, New South Wales, Australia

and more 21 locations

Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer

Phase 2
Completed
Conditions
Bone Loss
Prostate Cancer
Interventions
Other: Placebo
Drug: Zoledronic acid
First Posted Date
2005-09-16
Last Posted Date
2013-07-11
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
60
Registration Number
NCT00181584
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

Phase 3
Completed
Conditions
Cancer Prostate
Interventions
First Posted Date
2005-09-15
Last Posted Date
2017-03-06
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
218
Registration Number
NCT00172055
Locations
🇧🇪

Novaris Investigative Site, Libramont, Belgium

🇧🇪

Novartis Investigative Site, Woluwe-Saint-Lambert, Belgium

A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Phase 4
Completed
Conditions
Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated
Interventions
First Posted Date
2005-09-15
Last Posted Date
2012-04-30
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
43
Registration Number
NCT00172016

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Phase 3
Completed
Conditions
Bone Loss
Breast Cancer
Interventions
First Posted Date
2005-09-15
Last Posted Date
2012-04-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1065
Registration Number
NCT00171340
Locations
🇻🇪

Novartis Investigative Site, Caracas, Venezuela

🇹🇭

Ratchathew, Khonkaen, Thailand

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Phase 3
Terminated
Conditions
Multiple Myeloma Stage I
Interventions
Drug: Zoledronic acid
Dietary Supplement: Calcium / Vitamin D
First Posted Date
2005-09-15
Last Posted Date
2012-04-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
143
Registration Number
NCT00171925
Locations
🇩🇪

Novartis Investigative Site, Berlin, Germany

The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2005-09-15
Last Posted Date
2012-04-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
527
Registration Number
NCT00171314
Locations
🇪🇸

Novartis Investigative Site, Valencia, Spain

Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis

Phase 4
Completed
Conditions
Renal Cell Cancer
Neoplasm Metastasis
Interventions
First Posted Date
2005-09-15
Last Posted Date
2016-11-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
50
Registration Number
NCT00172003
Locations
🇩🇪

Novartis investigative Site, Offenbach, Germany

© Copyright 2025. All Rights Reserved by MedPath