The Alliance for Better Bone Health Responds to Fosamax Actonel Comparison Trial Results

The Alliance for Better Bone Health announced its response to the results of Merck’s bone mineral density (BMD) study released today.

“Bone mineral density (BMD) is important for determining if a patient needs therapy, but when determining which therapy, fracture reduction is the clinically relevant endpoint,” says Dr. Nora Zorich, M.D., Ph.D., Head of Drug Development, P&G Pharmaceuticals. “If Merck had intended to fully compare efficacy, they would have run a head-to-head fracture trial.”Merck’s own vice president of clinical research was quoted to this effect in response to another comparative BMD trial, “People can’t interpret this kind of data without looking at longer-term fracture trials.” The Alliance for Better Bone Health believes that this BMD trial should not be used as a head-to-head comparison of efficacy of osteoporosis treatments. In fact, Merck’s own data for different doses of Fosamax(R) have shown markedly different effects on BMD, but similar effects on fracture.The National Institutes of Health (NIH) states, “Fracture prevention is the primary goal in the treatment of osteoporosis.” Many studies have shown that increases in BMD correlate poorly to fracture risk reduction. Using differences in BMD increases to compare the efficacy of different therapies is potentially misleading. Actonel(R) is still the only osteoporosis therapy proven to reduce vertebral fractures in just one year, and Actonel significantly reduces the risk of both vertebral and non-vertebral fractures over three and five years. These non-vertebral fracture sites are those most commonly associated with osteoporosis and include hip, pelvis, wrist, humerus, clavicle and leg. The Alliance remains committed to leading science by partnering with the medical community to better understand all the elements that contribute to fracture-resistant bone.About Actonel(R) (risedronate sodium tablets)Actonel is developed by Procter & Gamble Pharmaceuticals and co-marketed by Procter & Gamble Pharmaceuticals and Aventis. Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment 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 ((>=) 7.5 mg/d prednisone or equivalent) for chronic diseases.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.In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent). Please visit www.actonel.com for full prescribing information for Actonel. (Source: Buisnesswire, Sept 2004)