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Zoledronic acid i.v. 5 years
Zoledronic acid i.v. inhibits bone resorption by acting as a bisphosphonate.
Zoledronic acid i.v. inhibits bone resorption by acting as a bisphosphonate. Used for Treatment of hypercalcemia of malignancy, treatment of bone metastases in patients with hormone-refractory prostate cancer, treatment of multiple myeloma and bone metastases in patients with breast cancer, treatment of osteoporosis in postmenopausal women, Prevention of skeletal fractures in patients with multiple myeloma and bone metastases from solid tumors.
At a glance
| Generic name | Zoledronic acid i.v. 5 years |
|---|---|
| Sponsor | Ludwig-Maximilians - University of Munich |
| Drug class | Bisphosphonate |
| Target | Hydroxyapatite |
| Modality | Small molecule |
| Therapeutic area | Oncology, Bone Diseases |
| Phase | Phase 3 |
Mechanism of action
Bisphosphonates like zoledronic acid bind to hydroxyapatite in bone, inhibiting osteoclast-mediated bone resorption. This leads to a decrease in bone turnover and an increase in bone density.
Approved indications
- Treatment of hypercalcemia of malignancy, treatment of bone metastases in patients with hormone-refractory prostate cancer, treatment of multiple myeloma and bone metastases in patients with breast cancer, treatment of osteoporosis in postmenopausal women
- Prevention of skeletal fractures in patients with multiple myeloma and bone metastases from solid tumors
Common side effects
- Renal impairment
- Hypocalcemia
- Nausea
- Vomiting
- Fever
- Fatigue
- Bone pain
- Headache
- Dizziness
- Muscle pain
Key clinical trials
- 1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids (PHASE3)
- Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis (PHASE3)
- Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older (PHASE3)
- Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis (PHASE4)
- Simultaneous Study of Gemcitabine-Docetaxel Combination Adjuvant Treatment, as Well as Extended Bisphosphonate and Surveillance-Trial (PHASE3)
- THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM) (PHASE2)
- Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zoledronic acid i.v. 5 years CI brief — competitive landscape report
- Zoledronic acid i.v. 5 years updates RSS · CI watch RSS
- Ludwig-Maximilians - University of Munich portfolio CI