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Effects of risedronate treatment on bone density and vertebral fracture in patients on corticosteroid therapy.

Abstract：

:Men and women (n = 518) receiving moderate-to-high doses of corticosteroids were enrolled in two studies with similar protocols and randomly assigned to receive either placebo or risedronate (2.5 or 5 mg) for 1 year. All patients received daily calcium supplementation (500-1000 mg), and most also received supplemental vitamin D (400 IU). The primary endpoint was the difference between the placebo and active groups in lumbar spine bone mineral density (BMD) at 1 year; changes in BMD at other sites, biochemical markers of bone turnover, and the incidence of vertebral fractures were also assessed. In the overall population, the mean (SE) lumbar spine BMD increased 1.9 +/- 0.38% from baseline in the risedronate 5 mg group (P < 0.001) and decreased 1.0 +/- 0.4% in the placebo group (P = 0. 005). BMD at the femoral neck, trochanter, and distal radius increased or was maintained with risedronate 5 mg treatment, but decreased in the placebo group. Midshaft radius BMD did not change significantly in either treatment group. The difference in BMD between the risedronate 5 mg and placebo groups was significant at all skeletal sites (P < 0.05) except the midshaft radius at 1 year. The 2.5 mg dose also had a positive effect on BMD, although of a lesser magnitude than that seen with risedronate 5 mg. A significant reduction of 70% in vertebral fracture risk was observed in the risedronate 5 mg group compared with the placebo group (P = 0.01). Risedronate was efficacious in both men and women, irrespective of underlying disease and duration of corticosteroid therapy, and had a favorable safety profile, with a similar incidence of upper gastrointestinal adverse events in the placebo and active treatment groups. Daily treatment with risedronate 5 mg significantly increases BMD and decreases vertebral fracture risk in patients receiving moderate-to-high doses of corticosteroid therapy.

journal_name

Calcif Tissue Int

journal_title

Calcified tissue international

authors

Wallach S,Cohen S,Reid DM,Hughes RA,Hosking DJ,Laan RF,Doherty SM,Maricic M,Rosen C,Brown J,Barton I,Chines AA

doi

10.1007/s002230001146

subject

Has Abstract

pub_date

2000-10-01 00:00:00

pages

277-85

issue

eissn

0171-967X

issn

1432-0827

pii

10.1007/s002230001146

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Effects of risedronate treatment on bone density and vertebral fracture in patients on corticosteroid therapy.