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

Prevention of Bone Loss After Acute SCI by Zoledronic Acid

Phase 2

Completed

Conditions: Bone Loss
Spinal Cord Injury
Osteoporosis
Acute Spinal Cord Injury

Interventions: Drug: Zoledronic acid
Drug: Placebo

First Posted Date: 2014-12-25

Last Posted Date: 2021-06-29

Lead Sponsor: Northwestern University

Target Recruit Count: 60

Registration Number: NCT02325414

Locations: 🇺🇸
Rehabilitation Institute of Chicago, Chicago, Illinois, United States
🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

Prolonged Protection From Bone Disease in Multiple Myeloma

Phase 4

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Zoledronic acid

First Posted Date: 2014-11-10

Last Posted Date: 2023-02-17

Lead Sponsor: Thomas Lund

Target Recruit Count: 158

Registration Number: NCT02286830

Locations: 🇩🇰
Odense University Hospital, Odense C, Denmark

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Phase 4

Completed

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: denosumab
Drug: teriparatide
Drug: Zoledronic acid

First Posted Date: 2014-06-27

Last Posted Date: 2021-02-09

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 76

Registration Number: NCT02176382

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Zoledronic Acid in Rheumatoid Arthritis

Phase 3

Terminated

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Zoledronic acid

First Posted Date: 2014-04-25

Last Posted Date: 2019-02-22

Lead Sponsor: Carmen Gómez-Vaquero

Target Recruit Count: 28

Registration Number: NCT02123264

Locations: 🇪🇸
Hospital de Viladecans, Viladecans, Barcelona, Spain
🇪🇸
Hospital Residència Sant Camil, Sant Pere de Ribes, Barcelona, Spain
🇪🇸
Hospital Universitario La Paz, Madrid, Spain

and more 8 locations

Genetics in Predicting Risk of Bisphosphonate-Related Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid

Not Applicable

Withdrawn

Conditions: Musculoskeletal Complications
Malignant Neoplasm

Interventions: Drug: zoledronic acid
Other: pharmacological study

First Posted Date: 2014-02-24

Last Posted Date: 2017-04-11

Lead Sponsor: University of Southern California

Registration Number: NCT02069340

Locations: 🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
J.Craig Venter Institute-San Diego, San Diego, California, United States

Zoledronic Acid Administration in Acute Spinal Cord Injury

Phase 4

Completed

Conditions: Disuse Osteoporosis

Interventions: Drug: Zoledronic acid

First Posted Date: 2014-01-23

Last Posted Date: 2018-03-14

Lead Sponsor: James J. Peters Veterans Affairs Medical Center

Target Recruit Count: 21

Registration Number: NCT02042872

Locations: 🇺🇸
Kessler Institute for Rehabilitation, West Orange, New Jersey, United States

Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Zoledronic acid
Drug: Denosumab
Drug: Placebo to Denosumab
Drug: Standard Chemotherapy
Drug: Placebo to Zoledronic Acid

First Posted Date: 2013-09-26

Last Posted Date: 2021-10-25

Lead Sponsor: Amgen

Target Recruit Count: 226

Registration Number: NCT01951586

Locations: 🇬🇧
Research Site, Preston, United Kingdom

A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors

Phase 3

Completed

Conditions: Fractures, Bone

Interventions: Biological: Denosumab 70 mg/mL
Drug: Zoledronic acid 4 mg
Drug: Placebo IV
Drug: Placebo SC
Dietary Supplement: Calcium supplement
Dietary Supplement: Vitamin D supplement

First Posted Date: 2013-08-12

Last Posted Date: 2017-01-16

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 487

Registration Number: NCT01920568

Locations: 🇨🇳
GSK Investigational Site, Taoyuan, Taiwan

The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer

Phase 4

Completed

Conditions: Breast Cancer

Interventions: Drug: Pamidronate
Drug: Zoledronic acid
Drug: placebo

First Posted Date: 2013-07-25

Last Posted Date: 2017-07-07

Lead Sponsor: Ottawa Hospital Research Institute

Target Recruit Count: 74

Registration Number: NCT01907880

Locations: 🇨🇦
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)

Phase 3

Terminated

Conditions: Bone Demineralization Lesions in the Injured Marrow

Interventions: Drug: NA Cl
Drug: Zoledronic acid

First Posted Date: 2013-03-01

Last Posted Date: 2018-02-28

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 12

Registration Number: NCT01802658

Locations: 🇫🇷
Institut Régional de Réadaptation Nancy, Nancy, France
🇫🇷
Centre Mutualiste Neurologique Propara, Montpellier, France
🇫🇷
Centre Bouffard - Vercelli CAP Cerbère, Cerbère, France

and more 6 locations

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