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Study shows Actonel reduces vertebral fracture risk 70 percent in patients on chronic steroid therapy

ednisone or equivalent) for chronic diseases (including asthma, chronic obstructive pulmonary disease (COPD), lupus, irritable bowel disease (IBD), and rheumatoid arthritis) are at risk.

Treatment and Prevention Ideally, measures against GIO should begin prior to or at the start of glucocorticoid therapy.
The American College of Rheumatology recommends bisphosphonates as the first-line treatment for GIO in postmenopausal women and men initiating high doses of glucocorticoid therapy (>3 months duration), along with modification of lifestyle risk factors and calcium and vitamin D supplementation.

Actonel (risedronate sodium tablets) 5 mg is the only therapy approved by the United States Food and Drug Administration (FDA) for both treatment and prevention of GIO. Specifically, Actonel is indicated for the treatment and prevention of GIO in men and women initiating or continuing oral glucocorticoid treatment (>7.5 mg/d prednisone or equivalent) for chronic diseases.

Actonel (risedronate sodium tablets) demonstrated a 70 percent reduction in vertebral fractures in just 1 year (p=0.01, absolute risk reduction 10.8 percent). This is from a combined analysis of two one-year clinical studies in 518 patients initiating or on glucocorticoid therapy. All patients received 500 to 1,000 mg/d calcium. Vertebral fractures were confirmed radiographically; some were associated with symptoms.

Summary

Glucocorticoid therapy is essential for a large number of people who suffer from inflammatory and autoimmune diseases, but its benefits are often accompanied by serious adverse side effects, including increased risk of osteoporosis.
With careful evaluation, monitoring and treatment planning, the risk of significant bone loss and fracture risk from long-term or chronic glucocorticoid therapy can be minimized.


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Contact: Jim Guarnera
jguarner@hillandknowlton.com
212-885-0303
Hill and Knowlton
24-Oct-2001


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