Randomized Trial of the Effects of Risedronate on Vertebral Fractures in Women with Established Postmenopausal Osteoporosis |
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Authors: | J-Y Reginster H W Minne O H Sorensen M Hooper C Roux M L Brandi B Lund D Ethgen S Pack I Roumagnac R Eastell |
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Institution: | Centre Universitaire d'Investigation du Métabolisme Osseux et du Cartilage Articulaire, University of Liège, Belgium. |
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Abstract: | The purpose of this randomized, double-masked, placebo-controlled study was to determine the efficacy and safety of risedronate
in the prevention of vertebral fractures in postmenopausal women with established osteoporosis. The study was conducted at
80 study centers in Europe and Australia. Postmenopausal women (n= 1226) with two or more prevalent vertebral fractures received risedronate 2.5 or 5 mg/day or placebo; all subjects also
received elemental calcium 1000 mg/day, and up to 500 IU/day vitamin D if baseline levels were low. The study duration was
3 years; however, the 2.5 mg group was discontinued by protocol amendment after 2 years. Lateral spinal radiographs were taken
annually for assessment of vertebral fractures, and bone mineral density was measured by dual-energy X-ray absorptiometry
at 6-month intervals. Risedronate 5 mg reduced the risk of new vertebral fractures by 49% over 3 years compared with control
(p<0.001). A significant reduction of 61% was seen within the first year (p= 0.001). The fracture reduction with risedronate 2.5 mg was similar to that in the 5 mg group over 2 years. The risk of nonvertebral
fractures was reduced by 33% compared with control over 3 years (p= 0.06). Risedronate significantly increased bone mineral density at the spine and hip within 6 months. The adverse-event
profile of risedronate, including gastrointestinal adverse events, was similar to that of control. Risedronate 5 mg provides
effective and well-tolerated therapy for severe postmenopausal osteoporosis, reducing the incidence of vertebral fractures
and improving bone density in women with established disease.
Received: 29 September 1999 / Accepted: 10 November 1999 |
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Keywords: | :Bisphosphonates – Bone mineral density – Osteoporosis – Postmenopausal women – Risedronate – Vertebral fracture |
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