# Zoledronic acid

Source: https://onco.cc/drugs/zoledronic-acid/  
OnCo record `zoledronic-acid` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Zoledronic acid (Zometa) is a fifteen-minute infusion given every few weeks or months to strengthen bone and prevent fractures, spinal cord compression and the need for radiotherapy in people with myeloma or cancer that has spread to bone; it also treats dangerously high calcium caused by cancer.

## Summary

Zoledronic acid was approved by the FDA in August 2001 for hypercalcaemia of malignancy (two randomised trials against pamidronate showed faster and more complete normalisation of calcium) and in 2002 for multiple myeloma and bone metastases from solid tumours in conjunction with antineoplastic therapy, on trials in breast cancer, prostate cancer, lung and other solid tumours that reduced skeletal-related events. The EU authorised Zometa in 2001. Every-12-week dosing was shown non-inferior to monthly (CALGB 70604), and adjuvant zoledronic acid reduces recurrence and death in postmenopausal early breast cancer (EBCTCG meta-analysis), an off-label but guideline-endorsed use. Osteonecrosis of the jaw, renal impairment (dose adjustment and creatinine monitoring) and acute-phase reactions after the first dose are the main risks. Denosumab is the alternative when renal function is poor.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: Reclast / Aclasta (osteoporosis formulation); Zoledronate
- Tags: nci-list; generic; supportive
- Brand: Zometa
- Modality: Nitrogen-containing bisphosphonate (intravenous)
- Mechanism: Binds bone mineral and inhibits farnesyl pyrophosphate synthase in osteoclasts, blocking prenylation of signalling proteins and inducing osteoclast apoptosis; reduces bone resorption and calcium release.
- Approvals: US 2001: Hypercalcaemia of malignancy; US 2002: Multiple myeloma and bone metastases from solid tumours, with antineoplastic therapy; EU 2001: Prevention of skeletal-related events in advanced malignancies involving bone; tumour-induced hypercalcaemia

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Zoledronic_acid
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=zoledronic%20acid
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/zoledronicacid
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zometa

## Connected records

- drugs: [Denosumab](https://onco.cc/drugs/denosumab/), [Ibandronic acid](https://onco.cc/drugs/ibandronic-acid/), [Pamidronate](https://onco.cc/drugs/pamidronate/)
- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Bone loss caused by cancer treatment, and what rebuilds it](https://onco.cc/technologies/cancer-treatment-bone-loss/), [Bone-modifying agents (bisphosphonates, denosumab)](https://onco.cc/technologies/bone-modifying-agents/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- terms: [Bone metastases and skeletal-related events](https://onco.cc/terms/bone-metastases/), [Palliation in advanced triple-negative breast cancer: brain, bone, pleura, skin and end of life](https://onco.cc/terms/tnbc-symptom-control-palliation/), [Palliation in lung cancer: breathlessness, pleural effusion, blocked airway, bone and brain](https://onco.cc/terms/lung-palliation-breathlessness-effusion-obstruction/), [Seed and soil hypothesis of metastasis (Paget)](https://onco.cc/terms/seed-and-soil-hypothesis/)
- trials: [Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide](https://onco.cc/trials/nct00083382/), [Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma](https://onco.cc/trials/nct02739594/), [Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma](https://onco.cc/trials/nct00033332/), [HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer](https://onco.cc/trials/nct00412022/), [Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer](https://onco.cc/trials/nct00326820/), [PEACE-3 (EORTC 1333)](https://onco.cc/trials/peace-3/), [STAMPEDE](https://onco.cc/trials/stampede/)
- key papers: [STOpCaP: docetaxel or bisphosphonates added to standard of care in hormone-sensitive prostate cancer, a systematic review and meta-analysis](https://onco.cc/key-papers/paper-vale-stopcap-docetaxel-bisphosphonates-lancet-oncol-2016/)

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