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Title: Zoledronic Acid Markedly Effective Against MGUS Bone Loss: Presented at ASH

"Zoledronic Acid Markedly Effective Against MGUS Bone Loss: Presented at ASH"

By John Gever ATLANTA, GA -- December 13, 2007 -- Zoledronic acid increases bone mineral density in the lumbar spine and hip in patients with monoclonal gammopathy of undetermined significance (MGUS), according to a prospective open-label study. The results were presented here on December 10 at the 49th American Society of Hematology (ASH) Annual Meeting and Exposition by James R. Berenson, MD, President, Oncotherapeutics Inc., Los Angeles, California. MGUS is a disorder of white blood cells affecting about 5% of people over the age of 70 years in the United States. Its effects include increased bone resorption and hence an increased risk for fracture. In their study, Dr. Berenson and colleagues investigated a regimen of zoledronic acid given in three 4-mg IV doses 6 months apart. Patients were evaluated for effects on bone mineral density (BMD) at baseline and 1 month after the final dose. Other endpoints included fracture, progression to serious hematologic malignancies, and other safety issues. Fifty-four patients with osteoporosis or osteopenia and a diagnosis of MGUS were enrolled. They had not taken oral bisphosphonates or fluoride for more than 3 months in the previous 2 years or taken any IV bisphosphonates. They were not taking systemic steroids or other medications known to affect osteoclast activity. Relative to baseline, BMD in the lumbar spine increased by a mean of 25.5% ([P =.0042) and increased in the hip by a mean of 14.4% (P =.0046).

No patients sustained new fractures or osteonecrosis of the jaw during the trial. One patient developed chronic lymphocytic leukemia during treatment. No other hematologic malignancies were seen. No cases of significant renal impairment were recorded.

"Zoledronic acid significantly improves BMD for MGUS patients with bone loss," the researchers said. They added that the drug appeared to be safe and well tolerated, and called it an "effective treatment to prevent development of new fractures in this high-risk population."

The study was funded by Novartis, makers of zoledronic acid under the trade name Zometa.

[Presentation title: Zoledronic Acid (ZOL) Markedly Improves Bone Mineral Density (BMD) for Patients (Pts) With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Bone Loss. Abstract 3606]

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