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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

Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

Phase 4
Completed
Conditions
Osteoporosis
Interventions
Other: Placebo
Drug: Zoledronic acid
First Posted Date
2010-12-28
Last Posted Date
2018-12-19
Lead Sponsor
Spokane Joint Replacement Center
Target Recruit Count
51
Registration Number
NCT01267279

Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma

Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2010-11-04
Last Posted Date
2010-11-04
Lead Sponsor
Instituto Mexicano del Seguro Social
Target Recruit Count
320
Registration Number
NCT01234129
Locations
🇲🇽

Tertiary reference oncology center, Mexico, Distrito Federal, Mexico

Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)

Phase 2
Completed
Conditions
HIV Infection
Osteoporosis
Bone Loss
Osteopenia
Interventions
First Posted Date
2010-10-26
Last Posted Date
2018-06-26
Lead Sponsor
Emory University
Target Recruit Count
63
Registration Number
NCT01228318
Locations
🇺🇸

Grady Infectious Diseases Clinic (Ponce Center), Atlanta, Georgia, United States

Efficacy of Zoledronic Acid in Enhancement of Early Stability of Cementless Primary Hip Prosthesis

Phase 4
Completed
Conditions
Hip Osteoarthritis
First Posted Date
2010-10-08
Last Posted Date
2017-02-13
Lead Sponsor
Turku University Hospital
Target Recruit Count
49
Registration Number
NCT01218035
Locations
🇫🇮

Turku University Hospital, Turku, Finland

1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

Phase 3
Completed
Conditions
Osteoporosis
Interventions
First Posted Date
2010-09-09
Last Posted Date
2019-09-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
25
Registration Number
NCT01197300
Locations
🇬🇧

Novartis Investigative Site, West Midlands, Birmingham, United Kingdom

Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms

Phase 2
Completed
Conditions
Ductal Carcinoma in Situ
Estrogen Receptor-positive Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions
First Posted Date
2010-09-03
Last Posted Date
2018-09-12
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
63
Registration Number
NCT01194440
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Zoledronic Acid in MS-patients With Osteoporosis

Phase 3
Terminated
Conditions
Osteoporosis
Multiple Sclerosis
Interventions
Drug: Placebo
Drug: Zoledronic Acid
Dietary Supplement: Calcium and Vitamin D combination
First Posted Date
2010-07-20
Last Posted Date
2013-11-26
Lead Sponsor
Novartis
Target Recruit Count
29
Registration Number
NCT01166178
Locations
🇩🇪

Novartis Investigative Site, Siegen, Germany

🇩🇪

Novartis investigative site, Stade, Germany

µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

Phase 4
Completed
Conditions
Osteoporosis, Osteopenia
Interventions
Other: Virtual Bone Biopsy
Drug: Teriparatide
Drug: Zoledronic Acid
First Posted Date
2010-06-30
Last Posted Date
2017-08-04
Lead Sponsor
University of Pennsylvania
Target Recruit Count
33
Registration Number
NCT01153425
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients

Phase 4
Completed
Conditions
First or Second Line HER2-negative Breast Cancer
Metastatic Disease Without Bone Metastasis
Interventions
Drug: Standard Therapy
Drug: Zoledronic acid
First Posted Date
2010-05-24
Last Posted Date
2014-05-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
44
Registration Number
NCT01129336
Locations
🇺🇸

Loma Linda University Loma Linda Cancer Center, Loma Linda, California, United States

🇺🇸

Wilshire Oncology Medical Group, La Verne, California, United States

🇺🇸

Florida Cancer Specialists DeptofFloridaCancerSpecialists, Fort Myers, Florida, United States

and more 30 locations

Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-04-07
Last Posted Date
2020-01-21
Lead Sponsor
Borstkanker Onderzoek Groep
Target Recruit Count
250
Registration Number
NCT01099436
Locations
🇳🇱

Leiden University Medical Center, Leiden, Netherlands

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