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Lupus Clinical Trials

New Medical Therapies™

Paget's Disease

September 5, 2005

Novartis issued positive results of a pair of clinical trials of zoledronic acid, for the treatment of Paget's disease. An NDA for the drug is currently under review by the FDA. Pooled results indicated that the drug was significantly more efficacious that the standard-of-care drug Actonel (risedronate) at 6 months, with 96% of subjects responding vs. 74% for the approved drug (p<0.001). Furthermore, zoledronic acid produced a significantly more rapid time to first response (64 days vs. 89 days from baseline; p<0.001), and maintained therapeutic response through one year in all but 1 of 113 subjects (vs. 21 of 82 for risedronate). Adverse events were similar between treatment groups; the most common overall adverse event for zoledronic acid was mild to moderate flu-like symptoms, which largely resolved within 4 days of infusion. These double-blind, active-controlled studies enrolled a combined 357 patients, who received a single 15 minute infusion of 5 mg zoledronic acid or a standard regimen of Actonel (30 mg for 60 days).

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.