TY - JOUR
T1 - Effect of Fluoride Treatment on the Fracture Rate in Postmenopausal Women with Osteoporosis
AU - Riggs, B. Lawrence
AU - Hodgson, Stephen F.
AU - O'fallon, W. Michael
AU - Chao, Edmund Y.s.
AU - Wahner, Heinz W.
AU - Muhs, Joan M.
AU - Cedel, Sandra L.
AU - Melon, L. Joseph
PY - 1990/3/22
Y1 - 1990/3/22
N2 - Although fluoride increases bone mass, the newly formed bone may have reduced strength. To assess the effect of fluoride treatment on the fracture rate in osteoporosis, we conducted a four-year prospective clinical trial in 202 postmenopausal women with osteoporosis and vertebral fractures who were randomly assigned to receive sodium fluoride (75 mg per day) or placebo. All received a calcium supplement (1500 mg per day). Sixty-six women in the fluoride group and 69 women in the placebo group completed the trial. As compared with the placebo group, the treatment group had increases in median bone mineral density of 35 percent (P<0.0001) in the lumbar spine (predominantly cancellous bone), 12 percent (P<0.0001) in the femoral neck, and 10 percent (P<0.0001) in the femoral trochanter (sites of mixed cortical and cancellous bone), but the bone mineral density decreased by 4 percent (P<0.02) in the shaft of the radius (predominantly cortical bone). The number of new vertebral fractures was similar in the treatment and placebo groups (163 and 136, respectively; P not significant), but the number of nonvertebral fractures was higher in the treatment group (72 vs. 24; P<0.01). Fifty-four women in the fluoride group and 24 in the placebo group had side effects sufficiently severe to warrant dose reduction; the major side effects were gastrointestinal symptoms and lower-extremity pain. We conclude that fluoride therapy increases cancellous but decreases cortical bone mineral density and increases skeletal fragility. Thus, under the conditions of this study, the fluoride—calcium regimen was not effective treatment for postmenopausal osteoporosis. (N Engl J Med 1990; 322:802–9.).
AB - Although fluoride increases bone mass, the newly formed bone may have reduced strength. To assess the effect of fluoride treatment on the fracture rate in osteoporosis, we conducted a four-year prospective clinical trial in 202 postmenopausal women with osteoporosis and vertebral fractures who were randomly assigned to receive sodium fluoride (75 mg per day) or placebo. All received a calcium supplement (1500 mg per day). Sixty-six women in the fluoride group and 69 women in the placebo group completed the trial. As compared with the placebo group, the treatment group had increases in median bone mineral density of 35 percent (P<0.0001) in the lumbar spine (predominantly cancellous bone), 12 percent (P<0.0001) in the femoral neck, and 10 percent (P<0.0001) in the femoral trochanter (sites of mixed cortical and cancellous bone), but the bone mineral density decreased by 4 percent (P<0.02) in the shaft of the radius (predominantly cortical bone). The number of new vertebral fractures was similar in the treatment and placebo groups (163 and 136, respectively; P not significant), but the number of nonvertebral fractures was higher in the treatment group (72 vs. 24; P<0.01). Fifty-four women in the fluoride group and 24 in the placebo group had side effects sufficiently severe to warrant dose reduction; the major side effects were gastrointestinal symptoms and lower-extremity pain. We conclude that fluoride therapy increases cancellous but decreases cortical bone mineral density and increases skeletal fragility. Thus, under the conditions of this study, the fluoride—calcium regimen was not effective treatment for postmenopausal osteoporosis. (N Engl J Med 1990; 322:802–9.).
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U2 - 10.1056/NEJM199003223221203
DO - 10.1056/NEJM199003223221203
M3 - Article
C2 - 2407957
AN - SCOPUS:0025374223
SN - 0028-4793
VL - 322
SP - 802
EP - 809
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 12
ER -