Zoledronic acid


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Company: Novartis
Approval Status: FDA  Approved February 2002
Specific Treatments: Multiple myeloma; bone metastases from solid tumors
Drug: Zoledronic acid



Zometa has been approved for the treatment of multiple myeloma and for patients with bone metastases from solid tumors. For prostate cancer, which is included in this approval, patients should have progressed after treatment with at least one hormonal therapy. The drug is indicated for use in conjunction with standard antineoplastic therapy.

It is a bisphosphonate that works by inhibiting the breakdown of bone (resorption). The drug was originally approved in August 2001 for the treatment of hypercalcemia of malignancy, a common life-threatening metabolic complication associated with cancer.



The safety and effectiveness of Zometa was supported by three large international trials that included more than 3,000 subjects with multiple myeloma, breast cancer, prostate cancer, lung cancer and other solid tumors. The three trials consisted of a pamidronate-controlled trial in breast cancer and multiple myeloma, a placebo-controlled trial in prostate cancer, and a placebo-controlled trial in other solid tumors. Results demonstrated that it decreased skeletal complications of subjects with multiple myeloma or metastases from solid tumors. In the two placebo-controlled trials, the number of subjects with skeletal events and the time to first skeletal-related event were both decreased compared to placebo.



Zometa, like other bisphosphonates, has been associated with renal insufficiency.

Adverse events reported in clinical trials include (but are not limited to) the following:

  • Arthralgia (joint pain)
  • Myalgia (muscle pain)
  • Fatigue
  • Gastrointestinal reactions
  • Anemia
  • Weakness
  • Cough
  • Dyspnea (difficult or labored breathing)
  • Edema



The principal pharmacologic action of zoledronic acid is inhibition of bone resorption. Although the antiresorptive mechanism is not completely understood, several factors are thought to contribute to this action. In vitro, zoledronic acid inhibits osteoclastic activity and induces osteoclast apoptosis. Zoledronic acid also blocks the osteoclastic resorption of mineralized bone and cartilage through its binding to bone. Zoledronic acid inhibits the increased osteoclastic activity and skeletal calcium release induced by various stimulatory factors released by tumors.

Source: centerwatch