To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Drug Reduces Fractures In Corticosteroid-Induced Osteoporosis URL: http://www.pslgroup.com/dg/34732.htm Doctor's Guide August 11, 1997
TORONTO -- August 11, 1997 -- Osteoporosis, one of the leading causes of bone fractures in women, is a well documented side-effect of long-term corticosteroid therapy. The New England Journal of Medicine reports in the August 7 issue on the first randomized, placebo-controlled clinical trial examining the prevention of corticosteroid-induced osteoporosis (CIO) in patients treated with intermittent cyclical therapy with etidronate, Didrocal.The study shows that treatment with this medication is associated with an 85 per cent reduction in the proportion of post-menopausal women with new spinal fractures. The 12-month results of the Canadian multi-centre study, led by Dr. J.D. Adachi and colleagues, show that Didrocal maintains bone mass and prevents fractures resulting from CIO. Didrocal is a non-hormonal prescription therapy that consists of etidronate disodium & calcium carbonate, currently authorized for the treatment of established post-menopausal osteoporosis. "No study has ever shown until now, a reduction in fracture rates in this population of post-menopausal women," said Dr. Adachi, Professor, Department of Medicine, St. Joseph's Hospital and McMaster University in Hamilton. "This study is the first to show that we can preserve bone mass and reduce the risk of fractures," he said adding that "when patients -- especially older women – have long-term corticosteroid use to contend with, it's quite literally the straw that breaks the camel's back." CIO has the potential to affect thousands of Canadians and millions worldwide. Corticosteroids are often used for such chronic diseases as asthma, autoimmune disorders such as rheumatoid arthritis and lupus, and in transplant patients. Bone loss rapid with corticosteroids Loss of bone mass resulting from corticosteroid use, occurs rapidly in the early months of therapy and persists at a lower rate throughout the course of treatment, thereby increasing the risk of fractures. According to Dr. Adachi, 40 to 50 per cent of patients on long-term corticosteroid therapy will end up with fractures, with women tending to be at higher risk. "The results of this clinical trial, therefore, are good news for men and women who use corticosteroids to control rheumatoid arthritis or other diseases," said Dr. Adachi. Study Results Highlights from the study in The New England Journal of Medicine show: -- Didrocal effectively maintained bone mass of the lumbar spine and proximal femur during the one-year treatment period, while the placebo group lost bone mass. -- 59 percent of the treatment group increased spinal bone density compared to 23 per cent in the placebo group. -- Only 3 percent of the post-menopausal treatment group had new spinal fractures versus 22 percent in the placebo group.This translates into an 85 percent reduction in the proportion of post-menopausal women with new spinal fractures who were on chronic corticosteroid therapy. -- No statistically significant difference between treatment groups in mean bone mass of the wrist (distal or midshaft radius) was demonstrated. -- Didrocal demonstrated a favourable safety profile, including no significant difference in upper gastrointestinal (GI) side effects versus placebo. The most common GI side effects were abdominal pain, diarrhea and constipation. However no patients withdrew as a consequence. Extensive worldwide experience in 22 countries shows that Didrocal, made by Procter & Gamble, increases spinal bone mass and significantly reduces the risk of spinal fractures, in a sub-population of patients with advanced osteoporosis and at higher risk for spinal fractures. The safety and efficacy of Didrocal for the prevention of CIO are still under investigation. Study Design The randomized, double-blind, placebo-controlled prevention study was conducted at 12 centres across Canada. The objective was to determine the effectiveness and safety of Didrocal versus placebo in preventing osteoporosis in patients using high-dose corticosteroids. The 141 study patients included 54 men, 17 premenopausal women and 70 post-menopausal women, ranging in age from 31 to 83 in the Didrocal group and 19 to 87 in the placebo group. The two groups were approximately equal in size. The second year of this trial will look at what happens to patients' bones when they stop receiving the Didrocal therapy. Osteoporosis is a degenerative bone disease characterized by progressive bone loss, fractures, deformity and disability. It affects up to one in four women over age 50 and also affects men. It occurs when the process of bone resorption exceeds new bone formation, leaving a net loss. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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