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New Phase III Data Presented for Once Monthly Dosing Regimen of Risedronate to Treat Postmenopausal Osteoporosis
Date:9/19/2007

-1000 IU). The primary efficacy endpoint of the study was to demonstrate non- inferiority of the risedronate 150 mg monthly regimen to the risedronate 5 mg daily regimen as assessed by percent change from baseline in LS BMD at 12 months. The 24 month results will be reported at a later time. At 12 months, the mean LS BMD increases were 3.54% and 3.43% for the monthly and daily regimens, respectively. The most common adverse events for risedronate 5 mg and risedronate 150 mg, respectively, were upper abdominal pain (6.1% vs. 8.2%), influenza (4.2% vs. 8.9%) and constipation (7.3% vs. 5.8%).

The trial was sponsored by The Alliance for Better Bone Health.

About Actonel(R) (risedronate sodium tablets)

Actonel is approved for the prevention and treatment of osteoporosis in postmenopausal women. Actonel has been proven to reduce the incidence of vertebral fractures, and nonvertebral fractures at a composite endpoint of leg, hip, pelvis, clavicle, humerus and wrist. The following doses are approved: Actonel 5 mg daily, Actonel 35 mg once-a-week, and Actonel 75 mg two consecutive days per month.

In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.

Among patients treated with bisphosphonates, there have be
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SOURCE The Alliance for Better Bone Health
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