Risedronate: A New Drug for Osteoporosis and Paget's Disease

Abstract

Risedronate is a pyridinyl bisphosphonate that has been recently approved by the U.S. Food and Drug Administration (FDA) for the prevention and treatment of postmenopausal osteoporosis, glucocorticoid induced osteoporosis, and for the treatment of Paget's disease of the bone. Risedronate inhibits osteoclast mediated bone resorption and modulates bone metabolism. The osteoporosis therapy clinical trials for risedronate demonstrated significant reductions in vertebral fractures and risk of new vertebral fractures within one year of treatment. Risedronate is generally well tolerated in most patients including patients with gastrointestinal disease. The overall side effects were comparable to placebo. Risedronate should not be administered in patients with hypocalcemia, known allergy to risedronate or any component of this product, or an inability to stand or sit upright for at least 30 minutes. It is not recommended to use in patients with severe kidney disease. Bisphosphonates have been associated with gastrointestinal disorders, such as dysphagia, esophagitis, and esophageal or gastric ulcers. Patients should be advised that taking the drug according to the instructions is important to minimize the risk of these adverse events. Additionally, patients should receive supplemental calcium and vitamin D if dietary intake is inadequate or plasma concentrations are below normal levels. No specific drug-drug interaction studies were performed but calcium/antacids/divalent cations/food may interfere with the absorption of risedronate and should be taken at a different time of the day. In summary, risedronate is an effective bisphosphonate for the prevention and treatment of postmenopausal osteoporosis that is now becoming a major public health issue due to an increase in aging population.