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| |  BONE AND MINERAL MEETING: Corticosteroid Treatment Increased Risk Of Vertebral Fracture SAN FRANCISCO, CA -- Dec. 14, 1998 -- A recent study released at the second joint scientific meeting of the American Society for Bone and Mineral Research and the International Bone and Mineral Society showed that high dose corticosteroid treatment (greater than 7.5 mg prednisone average daily dose) increased a patient's risk of developing vertebral fractures more than four-fold and doubled their risk of experiencing a hip fracture. This increased risk of hip and vertebral fracture occurred more quickly after initiation of corticosteroid therapy than previously understood and remained elevated until the patient discontinued steroid therapy. The study included 244,235 oral corticosteroid users and 244,235 controls. The controls matched the corticosteroid users in age and sex. In both groups, the average age was 57 years old, the percentage of females and males was a 60/40 split, respectively and the most frequent indication for treatment was respiratory disease. "Corticosteroids are necessary for millions of men and women who suffer from serious inflammatory diseases," said Cyrus Cooper, professor for rheumatology, Southampton General Hospital, UK, a co-investigator of the study. "The real news in this study is that it showed that patients on corticosteroid therapy were at risk of developing fractures much earlier than previously understood. Physicians who prescribe corticosteroids need to be aware of this risk and should treat their patients accordingly." Two prospective clinical studies also presented at the meeting showed that Actonel™ (risedronate), a novel, pyridinyl bisphosphonate in late-stage development by Procter & Gamble and Hoechst Marion Roussel, helped reduce the risk of vertebral fracture associated with corticosteroid use. Data from a pooled analysis of these studies showed that 5 mg risedronate reduced the incidence of vertebral fractures by 70 percent and helped prevent the loss of bone mass that is associated with corticosteroid therapy. In these studies, risedronate was generally well tolerated and upper gastrointestinal tolerability was similar for the risedronate and placebo groups. Further, these prospective clinical trials revealed that calcium or calcium plus vitamin D did not adequately protect against the increased risk of fracture and bone loss associated with steroid therapy. Specifically, one out of every six corticosteroid patients treated only with calcium or calcium plus vitamin D developed at least one vertebral fracture within 12 months. In the risedronate studies, a total of 518 patients were enrolled in two double-blind, randomised, multicentre, placebo-controlled trials conducted in Europe and the United States. The patients in the European study had been taking corticosteroids for six months or more at baseline. In the U.S. study, patients had newly-initiated corticosteroid therapy and had been on corticosteroids for three months or less. In both studies, patients were given either risedronate or a placebo daily, in addition to vitamin D and/or calcium. Results from the European study showed that in 12 months, 5 mg risedronate significantly increased bone mass at both the spine and hip versus calcium and vitamin D alone. In the U.S. study, calcium alone was not effective in preventing the rapid and significant bone loss which occurs in patients initiating corticosteroid therapy, whereas the men and women who also took 5 mg risedronate did not lose bone mass at the spine or hip. Actonel 30 mg tablets received marketing approval from the United States Food and Drug Administration in March, 1998 for the treatment of Paget's disease. In these two clinical studies on corticosteroid-induced osteoporosis, risedronate was generally well-tolerated. The majority of adverse experiences reported with risedronate were mild or moderate and did not require discontinuation of therapy. The most commonly reported adverse events were the following: back pain, arthralgia, infection, nausea, headache, peripheral edema, diarrhea and abdominal pain.
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