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Bone. 2006 Nov;39(5):1080-6. Epub 2006 Jun 14.

Etidronate for fracture prevention in amyotrophic lateral sclerosis: a randomized controlled trial.

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Department of Neurology, Mitate Hospital, 3237 Yugeta, Tagawa 826-0041, Japan.


Incidence of fractures is high in patients with amyotrophic lateral sclerosis (ALS) as compared to age-matched healthy controls. Our previous cross-sectional study showed that immobilization-induced hypercalcemia (i.e., increased bone resorption) and 25-hydroxyvitamin D (25-OHD) deficiency contribute to reduced bone mineral density (BMD). This study aims to address the possibility that treatment with etidronate may reduce the bone resorption and lower the incidence of fractures in patients with ALS. ALS patients were randomly assigned to daily treatment with 400 mg of etidronate (n = 41) or a placebo (n = 41) and followed for 2 years. At baseline, both groups had low BMD with high levels of serum ionized calcium and pyridinoline cross-linked carboxy-terminal telopeptide of type I collagen (ICTP). In the etidronate group, serum calcium and ICTP levels decreased significantly during the study period, while the levels in the placebo group were increased. Over 2 years, serum 25-OHD reduced to the potentially osteomalacic level (less than 5 mg/mL) in both groups. BMD decreased by 3.6% in the etidronate group and decreased by 12.1% in the placebo group (P < 0.0001). Fractures occurred in 7 patients in the placebo group and one patient in the risedronate group. The relative risk in the risedronate group as compared with the placebo group was 0.14 (95% confidence interval, 0.02 to 1.11). The number of fractures per 1000 patient-years was 14 and 92 for the etidronate and placebo groups, respectively. Treatment with etidronate prevents further loss of BMD in patients with ALS and leads to the prevention of fractures.

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