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Sustained-Release Sodium Fluoride in the Treatment of the Elderly With Established Osteoporosis
Craig D. Rubin, MD;
Charles Y. C. Pak, MD;
Beverley Adams-Huet, MS;
Harry K. Genant, MD;
Jiao Li, MD;
D. Sudhaker Rao, MD
Arch Intern Med. 2001;161:2325-2333.
Background We ascertained the safety and efficacy of fluoride in augmenting spinal
bone mass and reducing spinal fractures in older women with established osteoporosis.
We compared a combination of sustained-release sodium fluoride, calcium citrate,
and cholecalciferol (SR-NaF group) with calcium and cholecalciferol alone
(control group).
Methods Eighty-five ambulatory women aged 65 years or older with 1 or more nontraumatic
vertebral compression fractures were enrolled in a 42-month randomized, double-blind,
placebo-controlled trial. Primary outcome measures were vertebral fracture
rate, bone mass, and safety.
Results The vertebral fracture rate determined by means of computer assistance
in the SR-NaF group was significantly lower than that in the control group
(relative risk [RR], 0.32; 95% confidence interval [CI], 0.14-0.73; P = .007). Results of visual adjudicated inspection also
confirmed a significant reduction in fracture rate (RR, 0.40; 95% CI, 0.17-0.95; P = .04). Bone mineral density in L2 through L4 increased
significantly from baseline in the SR-NaF group by 5.4% (95% CI, 2.7%-8.2%; P<.001), and by 3.2% in the control group (95% CI, 0.8%-5.6%; P = .01). The between-group differences in bone mineral
density were not significant. The femoral neck and total hip bone mineral
density remained stable in the SR-NaF group and was not significantly different
from that of the control group. There were no significant differences in adverse
effects between groups.
Conclusion The SR-NaF group significantly decreased the risk for vertebral fractures
and increased spinal bone mass without reducing bone mass at the femoral neck
and total hip.
From the Department of Internal Medicine, University of Texas Southwestern
Medical Center at Dallas (Drs Rubin and Pak and Ms Adams-Huet); the Division
of Mineral Metabolism and the Osteoporosis and Arthritis Research Group, University
of CaliforniaSan Francisco (Drs Genant and Li); and Department of Internal
Medicine, Henry Ford Hospital, Detroit, Mich (Dr Rao).
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