Active Ingredient History
Zoledronic acid (Reclast, Aclasta, Zometa) is an intravenous, highly potent amino-bisphosphonate approved worldwide, including in the USA, EU and Japan for use in patients with primary or secondary osteoporosis or low bone mass (approved indications vary between countries). Its high affinity to and long half-life in bone, and long duration of action allow for once-yearly administration, which has the potential to improve adherence to therapy. Zoledronic acid once yearly for up to 3 years improved bone mineral density (BMD) at several skeletal sites, reduced fracture risk and bone turnover, and/or preserved bone structure and mass relative to placebo in clinical studies in patients with primary or secondary osteoporosis. While additional benefits were seen when treatment was continued for up to 6 years, as evidenced by a reduced risk of vertebral fractures and higher BMD relative to 3 years’ therapy, there was the minimal advantage of treatment beyond 6 years. Therefore, in patients with low fracture risk, treatment discontinuation should be considered after approximately 5 years’ therapy. Zoledronic acid administered annually or once in 2 years was also effective in preventing bone loss in patients with low bone mass. Zoledronic acid was generally well tolerated, with the most common adverse events (AEs) being transient, mild-to-moderate post-infusion symptoms, which decreased with subsequent infusions. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Chronic Kidney Disease-Mineral and Bone Disorder (approved 2001)
Hypercalcemia (approved 2001)
Adenocarcinoma (Phase 1)
Alveolar Bone Loss (Phase 4)
Anemia, Sickle Cell (Phase 1/Phase 2)
Arthritis, Rheumatoid (Phase 3)
Arthroplasty (Phase 4)
Bariatric Surgery (Phase 4)
beta-Thalassemia (Phase 3)
Bone Density (Phase 4)
Bone Diseases (Phase 4)
Bone Diseases, Metabolic (Phase 4)
Bone Marrow Diseases (Phase 3)
Bone Marrow Transplantation (Phase 2/Phase 3)
Bone Neoplasms (Phase 4)
Bone Resorption (Phase 2/Phase 3)
Brain Neoplasms (Phase 2)
Breast Diseases (Phase 2)
Breast Neoplasms (Phase 4)
Carcinoma, Ductal (Phase 2)
Carcinoma, Hepatocellular (Phase 2)
Carcinoma, Intraductal, Noninfiltrating (Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 4)
Carcinoma, Renal Cell (Phase 4)
Charcot-Marie-Tooth Disease (Phase 2/Phase 3)
Chondrosarcoma (Phase 1)
Complex Regional Pain Syndromes (Phase 3)
Critical Illness (Phase 2)
Crohn Disease (Phase 3)
Cystic Fibrosis (Phase 4)
Diabetes Complications (Phase 2/Phase 3)
Drugs, Investigational (Phase 4)
Drug Therapy (Phase 2)
Esophageal Neoplasms (Phase 1)
Fallopian Tubes (Early Phase 1)
Femur Head Necrosis (Phase 3)
Fractures, Bone (Phase 4)
Functional Status (Phase 3)
Gastrointestinal Neoplasms (Phase 2)
Genes, erbB-2 (Phase 2)
Giant Cell Tumor of Bone (Phase 3)
Hamartoma (Early Phase 1)
Healthy Volunteers (Phase 1)
Heart Transplantation (Phase 2/Phase 3)
Hematologic Neoplasms (Phase 3)
Hematopoietic Stem Cell Transplantation (Phase 1)
Hip Fractures (Phase 4)
HIV Infections (Phase 4)
Hodgkin Disease (Phase 1)
Hyperparathyroidism, Primary (Phase 4)
Hypocalcemia (Phase 4)
Intraocular Pressure (Phase 2)
Kidney Neoplasms (Phase 2)
Leiomyosarcoma (Phase 2)
Leukemia (Phase 2)
Leukemia, Myeloid, Acute (Phase 1)
Lewy Body Disease (Phase 4)
Liver Transplantation (Phase 4)
Low Back Pain (Phase 2)
Lung Neoplasms (Phase 4)
Lung Transplantation (Phase 4)
Lymphoma (Phase 3)
Lymphoma, Non-Hodgkin (Phase 3)
Macular Degeneration (Phase 2)
Mesothelioma (Phase 2)
Multiple Sclerosis (Phase 3)
Multiple System Atrophy (Phase 4)
Muscular Atrophy (Phase 2)
Musculoskeletal Diseases (Phase 3)
Myelodysplastic Syndromes (Phase 2)
Myeloproliferative Disorders (Phase 1)
Myositis (Phase 3)
Nasopharyngeal Neoplasms (Phase 2)
Neoplasm Metastasis (Phase 4)
Neoplasms (Phase 4)
Neoplasms by Site (Phase 2)
Neuroblastoma (Phase 1)
Neuroectodermal Tumors, Primitive (Phase 1)
Osteoarthritis, Hip (Phase 4)
Osteogenesis Imperfecta (Phase 4)
Osteoma, Osteoid (Phase 3)
Osteonecrosis (Phase 2)
Osteoporosis ()
Osteoporotic Fractures (Phase 4)
Osteosarcoma (Phase 2/Phase 3)
Ovarian Diseases (Early Phase 1)
Ovarian Neoplasms (Phase 2)
Paget Disease, Extramammary (Phase 4)
Pain (Phase 4)
Pancreatic Neoplasms (Phase 2)
Parkinson Disease (Phase 4)
Parkinsonian Disorders (Phase 4)
Periodontitis (Phase 4)
Plasmacytoma (Phase 3)
Pleural Effusion, Malignant (Phase 4)
Postmenopause (Phase 3)
Precancerous Conditions (Phase 2)
Primary Myelofibrosis (Phase 2)
Primary Prevention (Phase 3)
Progeria (Phase 2)
Reflex Sympathetic Dystrophy (Phase 3)
Rhabdomyosarcoma (Phase 1)
Sarcoma (Phase 3)
Sarcoma, Ewing (Phase 3)
Skeleton (Phase 4)
Small Cell Lung Carcinoma (Phase 2)
Spinal Cord Injuries (Phase 4)
Stomach Neoplasms (Phase 1)
Supranuclear Palsy, Progressive (Phase 4)
Thalassemia (Phase 4)
Triple Negative Breast Neoplasms (Phase 3)
Urination Disorders (Phase 3)
Urologic Neoplasms (Phase 2)
Uterine Cervical Neoplasms (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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