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The risk-benefit ratio of combined fluoride-calcium therapy in primary vertebral osteoporosis was examined prospectively in patients with at least one vertebral fracture. 257 patients were randomised to receive sodium fluoride 25 mg twice daily plus elemental calcium 1 g daily and a vitamin D2 supplement, and 209 received one of the alternative therapies usually prescribed in France. After a follow-up of 24 months the fluoride-calcium group showed a significantly lower rate of new vertebral fractures, the main adverse effect of the regimen being a higher incidence of osteoarticular pains in the ankle and foot; the risk of non-vertebral fractures was not increased, and digestive disorders arose with equal frequency in the two groups. Sodium fluoride 50 mg daily seems to represent a reasonable compromise in terms of anti-fracture effectiveness and side-effects.
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