Effects of Risedronate Treatment on Bone Density and Vertebral Fracture in Patients on Corticosteroid Therapy |
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| Authors: | S Wallach S Cohen D M Reid R A Hughes D J Hosking R F Laan S M Doherty M Maricic C Rosen J Brown I Barton A A Chines |
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| Institution: | (1) Hospital for Joint Diseases, New York, New York, USA, US;(2) Metroplex Clinical Research Center, Dallas, Texas, USA, US;(3) Aberdeen Royal Infirmary, Aberdeen, UK, GB;(4) St Peters Hospital, Chertsey, UK, GB;(5) Nottingham City Hospital, Nottingham, U.K., GB;(6) Department of Rheumatology, University Hospital Nijmegen Netherlands, NL;(7) Hull Royal Infirmary, Hull, UK, GB;(8) University of Arizona, Tucson, Arizona, USA, US;(9) St. Joseph Hospital, Bangor, Maine, USA, US;(10) CHUL, Ste-Foy, Quebec, Canada, CA;(11) Procter & Gamble Pharmaceuticals, Cincinnati, Ohio, USA, US |
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| 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.
Received: 11 October 1999 / Accepted: 1 May 2000 / Online publication: 27 July 2000 |
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| Keywords: | : Corticosteroid — Risedronate — Calcium — Vitamin D — BMD |
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