Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: A randomized trial

Long-term use of high-dose corticosteroids often results in bone loss, whic h may lead to osteoporosis-related fractures. This was a multicenter, doubl e-blind study in which 290 ambulatory men and women receiving high-dose ora l corticosteroid therapy (prednisone greater than or equal to 7.5 mg/day or equivalent) for 6 or more months were randomized to receive placebo, rised ronate 2.5 mg/day, or risedronate 5 mg/day for 12 months. All patients rece ived calcium 1 g and vitamin D 400 IU daily. The primary endpoint was lumba r spine bone mineral density (BMD) at month 12, Additional measurements inc luded BMD at the femoral neck and trochanter and the incidence of vertebral fractures, Overall, there were statistically significant treatment effects on BMD at 12 months at the lumbar spine (p < 0.001), femoral neck (p = 0.0 04), and trochanter (p = 0.010), Risedronate 5 mg increased BMD at 12 month s by a mean (SEM) of 2.9% (0.49%) at the lumbar spine, 1.8% (0.46%) at the femoral neck, and 2.4% (0.54%) at the trochanter, whereas BMD was maintaine d only in the control group, Although not powered to show fracture efficacy , we observed a reduction in the incidence of vertebral fractures of 70% in the combined risedronate treatment groups, relative to placebo (p = 0.042) , Risedronate was well tolerated, had a good safety profile, and was not as sociated with gastrointestinal adverse events. We conclude that risedronate increases BMD and potentially reduces the incidence of vertebral fractures in patients,vith corticosteroid-induced osteoporosis.