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Daily Risedronate Superior To Cyclical Etidronate For Involutional Osteoporosis

A daily regimen of risedronate was found to have superior efficacy to that of intermittent cyclical etidronate in increasing bone mineral density (BMD) among a cohort of Japanese patients with involutional osteoporosis.

Clinicians enrolled 235 patients with involutional osteoporosis in a multi-centre, randomized, double-masked, active (etidronate) controlled comparative trial. The clinical benefit of 2.5 mg daily risedronate and its effects on BMD of the lumbar spine was compared with etidronate, a representative of the bisphosphonates currently marketed in Japan.

The patients were randomized to receive either 2.5 mg/day of risedronate for 48 weeks, or intermittent treatment with etidronate in four cycles of two weeks treatment with 200 mg/day, followed by 10 week medication-free periods. Both treatment groups were given daily 200 mg calcium supplement in the form of the calcium lactate. Bone mineral density of the lumbar spine (L2-L4 BMD) was determined at 12, 24, 36 and 48 weeks by dual-energy X-ray absorptiometry.

The primary endpoint was the percent change in L2-L4 BMD from baseline, as well as changes in biochemical markers of bone turnover, plus comparative safety profiles.

The clinicians found a significant increase in L2-L4 BMD at 12 weeks in both the risedronate group of patients of 2.8%, and etidronate group of patients, of 1.8%. At the end of the trial, the increase in L2-L4 BMD in the risedronate group of patients, of 4.9%, was significantly greater than in the etidronate group of patients, of 3.1%.

Changes in bone resorption markers--urinary total deoxypyridinoline and N-terminal telopeptide of type I collagen-- from baseline to 48 weeks were -37.6% and -41.3%among the risedronate patient group, and -22.5% and -26.6% for patients in the etidronate group.

New vertebral fractures, or deterioration of existing fractures, were found among 2.8% of the patients in the etidronate group, compared with none among patients in the risedronate group. No significant difference in the incidence of adverse events was found between the two treatment regimens.
Osteoporosis International 2002;13:12:971-979. "A Comparison of the Effect of Risedronate and Etidronate on Lumbar Bone Mineral Density in Japanese Patients with Osteoporosis: A Randomized Controlled Trial"

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