ENDO: Risedronate Proves Effective In Five-Year Extended Trial
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ENDO: Risedronate Proves Effective In Five-Year Extended Trial

By Emma Patten-Hitt
Special to DG News

DENVER, CO -- June 24, 2001 -- A five-year trial of the osteoporosis drug, risedronate, indicates that benefits of fracture prevention observed in the first three years among postmenopausal women are also maintained after five years.

Dr. Nelson B. Watts, with Emory University, in Atlanta, Georgia, United States, reported the findings at the 83rd Annual Meeting of the Endocrine Society (ENDO) in Denver, Colorado.

The researchers note that treatment for osteoporosis may need to be continued for several years, but trials have only examined the effects of risedronate for three years.

Dr. Watts and his colleagues studied the long-term use of risedronate, which during three-year trials has been shown to reduce the risk of vertebral and non-vertebral fractures in women with postmenopausal osteoporosis.

Some women who completed three-year studies were enrolled in extension studies. A total of 179 continued to receive 5 mg and 172 received a placebo.

During the two-year extension, new vertebral fractures occurred in 22.3 percent of placebo-treated subjects, but occurred in only 11.1 percent of risedronate-treated patients. Over the five-year period, new vertebral fractures were reduced by 49 percent overall compared with the placebo treated women.

"The study showed that the fracture benefits observed in the first three years are maintained with continuing treatment through five years," the researchers note.

"These results are very reassuring,” Dr. Watts told Doctor’s Guide. “It’s nice to have data from both three-year and five-year time points in which the bone looks normal under microscope," he said.

"Bone turnover is reduced, but it’s reduced by the same amount at three years and five years," Dr. Watts said. "You wouldn’t necessarily want to continue reduction in bone loss-so this finding is reassuring," he said

Dr. Watts also suggested that the results are likely to extend to the other bisphosphonate drug on the market, alendronate, although this drug has yet to be tested over a period of five years.

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