Zometa (zoledronic acid)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Multiple myeloma; bone metastases from solid tumors
General Information
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.
Zometa 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.
Clinical Results
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 Zometa 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.
Side Effects
Zometa, like other bisphosphonates, has been associated with
renal insufficiency.
Adverse events reported in clinical trials with Zometa 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
Mechanism of Action
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. (from
Zometa Prescribing Information)
Additional Information
