Register for Research: Early intervention with Actonel reduces risk of first vertebral fracture in postmenopausal women
OsteoporosisAugust 8, 2002
2002 AUG 8 - (NewsRx.com & NewsRx.net) -- Postmenopausal women with low spinal bone mineral density (BMD) and no previous history of vertebral fracture, who received Actonel (risedronate sodium tablets) 5 mg daily for up to 3 years, were 75% less likely to experience a first vertebral fracture than women in the control group, according to a new analysis.
Published in journal Osteoporosis International, the results confirm the fracture reduction efficacy of Actonel in patients without vertebral fractures.
Vertebral fractures are among the most common osteoporotic fractures. In the U.S., an estimated 700,000 vertebral fractures occur every year. Data show that among postmenopausal women who sustain a vertebral fracture, 1 out of 5 will suffer their next vertebral fracture within just 1 year, potentially leading to a fracture cascade.
"Osteoporosis, long considered a slow developing disease, can actually progress quickly once a fracture occurs. The ability to prevent a first fracture is crucial for clinicians in the fight against osteoporosis. This is extremely important since osteoporosis affects more than 10 million people in the U.S.," said Robert Heaney, MD, of Creighton University in Omaha, Nebraska. "This 75% reduction in the risk of first fracture helps confirm that Actonel is a clinically significant treatment for postmenopausal women with osteoporosis."
The analysis assessed the risk of the first vertebral fracture in 640 postmenopausal women enrolled in 4 previously reported studies. The women had low lumbar spine BMD (T score <-2.5) and no vertebral fractures at baseline. The Actonel 5 mg daily, placebo-controlled studies ranged in duration from 1.5-3 years.
First vertebral fractures were observed in only 2.6% of the women who received Actonel 5 mg daily compared with 9.4% in the control group (which translates to a 75% risk fracture reduction, p=3D0.002). All women received 1000 mg/d calcium and up to 500 IU/d vitamin D (if baseline levels were low).
The significant reduction in first vertebral fracture risk with Actonel is consistent with previously reported vertebral fracture reductions observed in postmenopausal women with existing vertebral fractures.
Actonel was codeveloped and comarketed by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals. Actonel 35 mg once-a-week and Actonel 5 mg daily are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (greater than or equal to7.5 mg/d prednisone or equivalent) for chronic diseases.
This article was prepared by Women's Health Weekly editors from staff and other reports.
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