Risedronate increases bone density and reduces vertebral fracture risk within one year in men on corticosteroid therapy

Limited information is available on the effect of bisphosphonates in men re ceiving corticosteroid therapy. We studied 184 men among the patients enrol led in two, double-blind, placebo-controlled, 1-year studies with similar p rotocols. The studies evaluated the effects of risedronate in patients begi nning corticosteroid treatment at a dose of at least 7.5 mg per day of pred nisone or equivalent (prevention study) or continuing long-term treatment o f corticosteroid at that dose (treatment study). The men received either pl acebo or risedronate (2.5 mg or 5 mg) daily, along with calcium supplementa tion (500-1000 mg). Endpoints included differences in bone mineral density (BMD) at the lumbar spine, femoral neck, and femoral trochanter, assessment of vertebral fractures, changes in biochemical markers of bone turnover, a nd overall safety. In the treatment study, risedronate 5 mg significantly ( P < 0.01) increased lumbar spine BMD by 4.8% at the lumbar spine, 2.1% at t he femoral neck, and 2.6% at the femoral trochanter compared with baseline values. In the prevention study, bone loss was prevented with risedronate 5 mg; in the placebo group, BMD decreased significantly (P < 0.01) by 3.4%, 3.3%, and 3.4% in the lumbar spine, femoral neck, and trochanter, respectiv ely, at 1 year. The differences between risedronate 5 mg and placebo groups were significant at all skeletal sites in the prevention study (P < 0.01) and at the lumbar spine in the treatment study (P < 0.001). The 2.5 mg dose also had a positive effect on BMD, although of a lesser magnitude than the 5 mg dose. When the data from the two studies were combined, the incidence of vertebral fractures decreased 82.4% (95% confidence interval, 36.6%-95. 1%) in the pooled risedronate groups compared with placebo (P = 0.008). Ris edronate was well tolerated in men, with a similar incidence of upper gastr ointestinal adverse events in the placebo and treatment groups. Daily treat ment with risedronate increases bone density and decreases vertebral fractu re risk within 1 year in men receiving corticosteroid therapy.