The prevention of hip fracture with risedronate and ergocalciferol plus calcium supplementation in elderly women with Alzheimer disease: a randomized controlled trial.
BACKGROUND
A high incidence of fractures, particularly of the hip, represents an important problem in patients with Alzheimer disease (AD), who are prone to falls and have osteoporosis. We previously found that deficiency of 25-hydroxyvitamin D and compensatory hyperparathyroidism cause reduced bone mineral density in female patients with AD. We address the possibility that treatment with risedronate sodium and ergocalciferol plus calcium supplementation may reduce the incidence of nonvertebral fractures in elderly women with AD.


METHODS
A total of 500 elderly women with AD were randomly assigned to daily treatment with 2.5 mg of risedronate sodium or a placebo, combined with 1000 IU of ergocalciferol and 1200 mg of elementary calcium, and followed up for 18 months.


RESULTS
At baseline, patients of both groups showed 25-hydroxyvitamin D deficiency with compensatory hyperparathyroidism. During the study period, bone mineral density in the risedronate group increased by 4.1% and decreased by 0.9% in the control group. Vertebral fractures occurred in 29 patients (24 hip fractures) in the control group and 8 patients (5 hip fractures) in the risedronate group. The relative risk in the risedronate group compared with the control group was 0.28 (95% confidence interval, 0.13-0.59).


CONCLUSIONS
Elderly patients with AD hypovitaminosis D are at increased risk for hip fracture. Treatment with risedronate and ergocalciferol may be safe and effective in reducing the risk of a fracture in elderly patients with AD.
Sato
Yoshihiro
Y
Department of Neurology, Mitate Hospital, Tagawa, Japan. y-sato@ktarn.or.jp
Kanoko
Tomohiro
T
Satoh
Kei
K
Iwamoto
Jun
J
D000058:Accidental Falls / Q000517:prevention & control / Q000706:statistics & numerical data; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000453:epidemiology*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D015897:Comorbidity; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004872:Ergocalciferols / Q000627:therapeutic use*; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006620:Hip Fractures / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D000068296:Risedronic Acid
D002121:Calcium Channel Blockers; D004872:Ergocalciferols; D000068296:Risedronic Acid; D012968:Etidronic Acid