Actonel - the FDA approved drug for osteoporosis treatment

01/25/10
In 2000, the FDA approved 5 mg Actonel (risedronate sodium) in tablets to be used in the treatment of osteoporosis in postmenopausal women. In addition, Actonel is approved for treatment of osteoporosis induced by glucocorticoids.

Why approval of Actonel is important? The main reason is that Actonel is the 1st drug for osteoporosis treatment that showed excellent results in reducing the occurrence of spinal fractures in one year of the therapy. According to the research data, around 20% of untreated patients with spinal fractures will experience a fracture again in just 12 months.

Also, postmenopausal women had a decreased fracture risk by 65% after a year treatment with Actonel compared to the women taking calcium as a supplement together with vitamin D, if necessary. The fractures reduction rate has been studied and confirmed by a number of different studies. That demonstrated that Actonel is the only drug able to reduce the spinal fractures occurrence in one year in patients with glucocorticoid-induced osteoporosis as well.

Robert Lindsay, College of Physicians and Surgeons, Department of Medicine, Columbia University, New York, says that osteoporosis progresses much faster than it was thought before. Actonel allows to reduce the risk of vertebral fractures in case of the timely diagnosis of osteoporosis.

Actonel is a well-tolerated drug even in patients with the diseases of gastrointestinal tract (ulcers, heartburn, etc.). 60% of patients who participated in the clinical trials of Actonel say they used non-steroid anti-inflammatory drugs which often cause gastrointestinal problems and 40% had a disorder from the gastric or intestinal side. In those patients, the evidence of GI problems was about the same compared to placebo.

Based on the result of different studies, the FDA has approved Actonel for the osteoporosis treatment in the USA. More than 14 countries in the world followed the FDA approval, and now Actonel is prescribed for the treatment and prevention of postmenopausal osteoporosis and maintenance and increase of bone mass in women undergoing long-term glucocorticoid therapy after reaching menopause.

Actonel is not recommended for use is patients with calcium deficiency and other bone and mineral metabolism disorders and severe kidney diseases. The drug may cause some gastrointestinal disorders like difficulty swallowing and esophageal irritation or ulcer. Sometimes, gastric ulcer may occur as well. In order to avoid the adverse reactions of Actonel, patients are recommended to take the drug with a full glass of water and stand or sit upright for at least 30 minutes after intake. Other side effects include upper respiratory tract infection and pain in muscles and joints do not require therapy discontinuation due to their mild to moderate nature.

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