Background Of the 518 patients enrolled in studies of patients initiating or on maintenance of glucocorticoid (GC) therapy (Prevention: less than 3 months on GC therapy and Treatment: greater than 6 months GC therapy), 186 were men. There were 77 men in the Prevention study and 109 in the Treatment study. The mean ages and lumbar spine T-scores were 59.5, -0.38 for the Prevention study and 56.2 and ?1.67 for the Treatment study respectively.
Methods Patients were randomised to receive placebo, or risedronate (RIS) 2.5 mg, or RIS 5 mg daily for 1 year in both studies. Patients were supplemented with elemental calcium 500 mg/day or elemental calcium 1 g/day and vitamin D 400 IU/day. Most men in the studies were taking GC therapy for either rheumatoid arthritis (38%) or lung disease (22%).
Results RIS 5 mg significantly increased BMD or prevented bone loss at both the spine and the hip in men (Table 1 Year BMD Mean (SE)% Change from Baseline in Men Taking Glucocorticoids). 23% (9 out of 38) of placebo patients had a new vertebral fracture compared with 5% in the risedronate 2.5 and 5 mg/day treated group (3 out of 58). The vertebral fracture risk reduction was 82% (p = 0.008) for pooled risedronate doses.
Conclusion In summary, these studies demonstrate that risedronate is effective in preventing bone loss in men recently on glucocorticoids and can increase BMD in men on long term glucocorticoid therapy.
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