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

Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism

Phase 4

Recruiting

Conditions: Primary Hyperparathyroidism

Interventions: Drug: Zoledronic acid 4 mg
Drug: Natriumklorid 9 mg/ml, Fresenius Kabi

First Posted Date: 2025-03-05

Last Posted Date: 2025-03-25

Lead Sponsor: University of Aarhus

Target Recruit Count: 140

Registration Number: NCT06859580

Locations: 🇩🇰
Aarhus University Hospital, Aarhus N, Central Region of Denmark, Denmark

Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors

Phase 1

Not yet recruiting

Conditions: Neuroblastoma
Rhabdomyosarcoma
Synovial Sarcoma
Peripheral Nerve Sheath Tumors
Clear Cell Sarcoma
Alveolar Soft Part Sarcoma
Desmoplastic Small Round Cell Tumor
Chordoma
Rhabdoid Tumor
Epithelioid Sarcoma

Interventions: Device: Miltenyi CliniMACS Prodigy ® system
Drug: Zoledronic acid

First Posted Date: 2024-10-03

Last Posted Date: 2025-03-07

Lead Sponsor: University of Florida

Target Recruit Count: 27

Registration Number: NCT06625190

Locations: 🇺🇸
University of Florida, Gainesville, Florida, United States

Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea

Phase 3

Recruiting

Conditions: FHA (Functional Hypothalamic Amenorrhea)

Interventions: Drug: Romosozumab
Drug: Placebo
Drug: Zoledronic acid

First Posted Date: 2024-08-01

Last Posted Date: 2025-04-02

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 114

Registration Number: NCT06533865

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of Virginia Medical Center, Charlottesville, Virginia, United States

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

Phase 1

Recruiting

Conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer

Interventions: Drug: Zumsemetinib
Drug: Capecitabine
Drug: Zoledronic acid
Drug: Denosumab

First Posted Date: 2024-04-18

Last Posted Date: 2025-02-04

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 152

Registration Number: NCT06374459

Locations: 🇺🇸
The University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid

Phase 3

Not yet recruiting

Conditions: Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors

Interventions: Drug: JMT103
Drug: zoledronic acid

First Posted Date: 2024-01-24

Last Posted Date: 2024-01-24

Lead Sponsor: Shanghai JMT-Bio Inc.

Target Recruit Count: 1360

Registration Number: NCT06221072

Sequential Therapies After Osteoanabolic Treatment

Recruiting

Conditions: Osteoporosis, Postmenopausal

Interventions: Drug: Zoledronate
Drug: Denosumab
Drug: Teriparatide
Drug: Romosozumab
Drug: Abaloparatide Injection (80 mcg)

First Posted Date: 2023-12-11

Last Posted Date: 2025-04-27

Lead Sponsor: 424 General Military Hospital

Target Recruit Count: 150

Registration Number: NCT06164795

Locations: 🇬🇷
251 Airforce & VA General Hospital, Athens, Greece
🇬🇷
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens, Athens, Greece
🇬🇷
, KAT General Hospital, Athens, Greece

and more 5 locations