23-Jul-2001 -

New Treatment Guidelines Recommend Bisphosphonates as First-line Therapy for Treatment of Glucocorticoid-Induced Osteoporosis

New treatment guidelines published in the current issue of Arthritis and Rheumatism by the American College of Rheumatology (ACR) recommend bisphosphonates as first-line therapy in conjunction with calcium and vitamin D for preventing and treating glucocorticoid-induced osteoporosis (GIO), or steroid-induced bone loss.

The guidelines state that for patients at risk for, or already experiencing GIO, a bisphosphonate is the recommended first-line treatment along with modification of lifestyle risk factors for osteoporosis. Actonel® (risedronate sodium tablets) 5mg is the only drug in the U.S. approved by the FDA for both prevention and treatment of GIO in men and women.

According to the ACR, more than 30 million Americans may be affected by diseases that are treated with glucocorticoid therapy (e.g. prednisone). Glucocorticoids are the primary therapy for many inflammatory and autoimmune diseases -- including asthma and rheumatoid arthritis – as well as many allergic conditions. In as little as 3 months, chronic steroids (>7.5 mg/d of prednisone or equivalent) can cause significant bone loss.

It is estimated that up to 50 percent of patients on chronic glucocorticoid therapy will experience osteoporotic fractures. Unfortunately, the majority of these patients do not receive treatment to prevent GIO.

Actonel® (risedronate sodium tablets) 5mg is the only therapy proven to reduce vertebral fracture incidence in GIO patients on chronic glucocorticoid treatment in just one year. A combined analysis of 2 clinical studies demonstrated that Actonel 5mg reduced the incidence of vertebral fracture by 70 percent in one year (19% of the 111 patients in the placebo group fractured compared to only 5% of the 111 patients in the Actonel 5mg group).

According to the new ACR guidelines, treatment with a bisphosphonate is recommended to prevent bone loss in all men and postmenopausal women in whom long-term glucocorticoid treatment at medium to high doses is being initiated or continued. The guidelines also recommend calcium and vitamin D supplementation in conjunction with bisphosphonate therapy.

About Actonel

Actonel 5 mg is indicated for the treatment and prevention of postmenopausal osteoporosis in women and GIO in men and women who are either initiating or continuing systemic glucocorticoid treatment (>7.5 mg/d prednisone or equivalent) for chronic diseases.

Actonel® (risedronate sodium tablets) should not be used in patients with low blood calcium, known allergy to Actonel, or an inability to stand or sit upright for at least 30 minutes. Low blood calcium 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 kidney disease.

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus), and esophageal or gastric ulcers. Patients should take Actonel with a full glass of plain water (6-8 oz.) to facilitate delivery to the stomach, and should not lie down for 30 minutes after taking the drug.

In clinical trials, Actonel was generally well tolerated. Most side effects were mild to moderate and did not require patients to stop taking Actonel. Overall, side effects regardless of causality, were comparable to placebo and included infection (primarily upper respiratory, placebo patients, 29.7% vs. Actonel patients 29.9%), back pain (23.6% vs. 26.1%), and joint pain (21.1% vs. 23.7%).

Facts, background information, dossiers
  • vitamin D
  • pain
  • diseases
  • rheumatology
  • rheumatoid arthritis
  • Postmenopausal Osteoporosis
  • metabolism
  • kidney diseases
  • glass
  • gastric ulcer
  • FDA
  • clinical trials
  • autoimmune diseases
  • allergies