Risedronate therapy prevents corticosteroid-induced bone loss - A twelve-month, multicenter, randomized, double-blind, placebo-controlled, parallel-group study

Objective. Risedronate, a new pyridinyl bisphosphonate, is a potent antires orptive bone agent. This study examines the safety and efficacy of daily, o ral risedronate therapy for the prevention of corticosteroid-induced bone l oss. Methods, This multicenter, randomized, double-blind, placebo-controlled, pa rallel-group study was conducted in 224 men and women who were initiating l ong-term corticosteroid treatment. Patients received either risedronate (2. 5 mg or 5 mg) or placebo daily for 12 months. Each patient also received 50 0 mg of elemental calcium daily, The primary outcome measure was the percen tage of change in lumbar spine bone mineral density (BMD). Secondary measur es included proximal femur BMD and incidence of vertebral fractures, Results, After 12 months, the lumbar spine BMD (mean +/- SEM) did not chang e significantly compared with baseline in the 5-mg (0.6 +/- 0.5%) or the 2. 5-mg (-0.1 +/- 0.7%) risedronate groups, while it decreased in the placebo group (-2.8 +/- 0.5%; P < 0.05), The mean differences in BMD between the 5- mg risedronate and the placebo groups were 3.8 +/- 0.8% at the lumbar spine (P < 0.001), 4.1 +/- 1.0% at the femoral neck (P < 0.001), and 4.6 +/- 0.8 % at the femoral trochanter (P < 0.001). A trend toward a decrease in the i ncidence of vertebral fracture was observed in the 5-mg risedronate group c ompared with the placebo group (5.7% versus 17.3%; P = 0.072), Risedronate was well tolerated, and the incidence of upper gastrointestinal adverse eve nts was comparable among the 3 groups. Conclusion. Risedronate therapy prevents bone loss in patients initiating l ong-term corticosteroid treatment.