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Alendronate - RCP evidence grades in osteoporosis

Authoring team

Spine: A Non-vertebral: A Hip: A

Alendronate's anti-fracture efficacy was demonstrated in the Fracture Intervention Trial (FIT) in postmenopausal women with established osteoporosis. The second arm of this study included 4,432 postmenopausal women with low femoral neck BMD, with a daily calcium intake of atleast 1000mg/day. The results of this 4 year trial showed significant increases in hip (5%) and spine BMD (6%), but only a reduction (rr 0.56) in in fractures in women with hip BMD t score <-2.5. A further study in 1908 postmenopausal women with low spine bone mass showed a significant decrease in non-vertebral fractures after 12 months on alendronate therapy (rr 0.56). There is also some data to suggest that intermiitent oral therapy either once or twice weekly may be similar to daily dosing.


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