BACKGROUND: There is a high incidence of hip fractures in patients after hemiplegic stroke. Bone mineral density is decreased on the hemiplegic side in patients after stroke, correlating with the immobilization-induced bone resorption, the degree of paralysis, and hypovitaminosis D. The purpose of this study is to evaluate the effectiveness of risedronate sodium, an inhibitor of bone resorption, on osteoporosis and the risk of hip fractures in men 65 years or older after stroke. METHODS: We conducted an 18-month randomized double-blind trial. Of 280 male patients 65 years or older who were poststroke, 140 received a daily dose of 2.5 mgrisedronate sodium and the other 140 received placebo. Incidence of hip fractures in the 2 groups was compared. RESULTS: Ten patients sustained hip fractures in the placebo group, and 2 hip fractures occurred in the risedronate group. The relative risk of a hip fracture was 0.19 (95% confidence interval, 0.04-0.89). The number of patients needing the treatment was 16 (95% confidence interval, 9-32). Bone mineral density increased by 2.5% in the risedronate group and decreased by 3.5% in the placebo group (P<.001). Urinary deoxypyridinoline, a bone resorption marker, decreased by 58.7% in the risedronate group and by 37.2% in the placebo group. CONCLUSION: Treatment with risedronate increases bone mineral density and reduces hip fractures in elderly men who are poststroke.
RCT Entities:
BACKGROUND: There is a high incidence of hip fractures in patients after hemiplegic stroke. Bone mineral density is decreased on the hemiplegic side in patients after stroke, correlating with the immobilization-induced bone resorption, the degree of paralysis, and hypovitaminosis D. The purpose of this study is to evaluate the effectiveness of risedronate sodium, an inhibitor of bone resorption, on osteoporosis and the risk of hip fractures in men 65 years or older after stroke. METHODS: We conducted an 18-month randomized double-blind trial. Of 280 male patients 65 years or older who were poststroke, 140 received a daily dose of 2.5 mg risedronate sodium and the other 140 received placebo. Incidence of hip fractures in the 2 groups was compared. RESULTS: Ten patients sustained hip fractures in the placebo group, and 2 hip fractures occurred in the risedronate group. The relative risk of a hip fracture was 0.19 (95% confidence interval, 0.04-0.89). The number of patients needing the treatment was 16 (95% confidence interval, 9-32). Bone mineral density increased by 2.5% in the risedronate group and decreased by 3.5% in the placebo group (P<.001). Urinary deoxypyridinoline, a bone resorption marker, decreased by 58.7% in the risedronate group and by 37.2% in the placebo group. CONCLUSION: Treatment with risedronate increases bone mineral density and reduces hip fractures in elderly men who are poststroke.