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Sustained-release sodium fluoride reduces vertebral fracture risk

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WESTPORT, CT (Reuters Health) – Treatment with a combination of sustained-release sodium fluoride, calcium citrate and cholecalciferol significantly decreases the risk of vertebral fracture and increases spinal bone mass in elderly patients with osteoporosis, according to a report in the October 22nd issue of the Archives of Internal Medicine.

Dr. Craig D. Rubin of the University of Texas Southwestern Medical Center in Dallas and colleagues conducted a 42-month randomized, double-blind, placebo-controlled study with 85 women (at least 65 years of age) with established osteoporosis. They compared the outcome of women treated with sodium fluoride, calcium and cholecalciferol (SR-NaF) with that of women treated with calcium and cholecalciferol alone (control group).

The researchers observed a 68% rate reduction in new or recurrent vertebral fractures in the SR-NaF group compared with the control group (relative risk, 0.32). Results of visual adjudicated inspection also confirmed a 60% reduction in the fracture rate in the SR-NaF group (relative risk, 0.40).

"Bone mineral density in L2 through L4 increased significantly from baseline in the SR-NaF group by 5.4% (p < 0.001), and by 3.2% in the control group (p = 0.01)," the investigators report. "The between-group differences in bone mineral density were not significant."

The femoral neck and total hip bone mineral density was maintained in both groups. The team observed no significant differences in adverse effects between groups.

"Our results suggest this combination of therapy safely reduces the risk for vertebral fractures by stimulating new bone formation by fluoride-mediated increased osteoblastic activity," Dr. Rubin and colleagues conclude. "In addition, the adequate provision of calcium and cholecalciferol reduces bone resorption," he adds. "Therefore, this combination therapy addresses two fundamental abnormalities underlying the pathophysiology of age-related osteoporosis."

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