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Slow-Release Sodium Fluoride in the Management of Postmenopausal Osteoporosis: A Randomized, Controlled Trial

Charles Y. C. Pak, MD; Khashayar Sakhaee, MD; Veronica Piziak, MD; Roy D. Peterson, RN; Neil A. Breslau, MD; Peggy Boyd, AD; John R. Poindexter, BS; Jean Herzog, RN; Ann Heard-Sakhaee, RN; Sharon Haynes, RN; Beverley Adams-Huet, MS; and Joan S. Reisch, PhD
[+] Article and Author Information

From the University of Texas Southwestern Medical Center, Dallas, Texas. Requests for Reprints: Charles Y.C. Pak, MD, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75235-8885. Grant Support: In part by grants R01AR-16061 and M01-RR00633 from the United States Public Health Service and by institutional funds.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1994;120(8):625-632. doi:10.7326/0003-4819-120-8-199404150-00001
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Objective: To test whether intermittent treatment with slow-release sodium fluoride and continuous calcium citrate supplementation inhibits vertebral fractures without causing fluoride complications.

Design: A placebo-controlled, randomized trial.

Setting: Outpatient setting of specialty clinics in Dallas and Temple, Texas.

Interventions: Slow-release sodium fluoride (25 mg twice daily) in repeated 14-month cycles (12 months on treatment followed by 2 months off treatment) compared with placebo. Both groups took calcium citrate (400 mg calcium twice daily) continuously.

Patients: 110 patients with postmenopausal osteoporosis were randomly assigned to two groups. In the slow-release sodium fluoride group, 48 of 54 patients completed more than 1 cycle of treatment (mean, 2.44 cycles/patient), whereas 51 of 56 patients in the placebo group completed at least 1 cycle (mean, 2.14 cycles/patient) in this interim analysis.

Measurements: Vertebral fracture rate and lumbar bone mineral content. Vertebral fractures were quantified from yearly radiographs. Bone mass was determined annually by densitometry.

Results: In the sodium fluoride group, the mean L2 to L4 bone mineral content increased by 4% to 6% in each cycle and the mean femoral neck bone density increased by 4.1% and 2.1% during the first two cycles, but the radial bone density did not change. The placebo group showed no statistical change in bone mass at any site. Compared with the placebo group, the sodium fluoride group had a lower individual new vertebral fracture rate (0.057/patient cycle compared with 0.204/patient cycle, P = 0.017), a higher fracture-free rate (83.3% compared with 64.7%, P = 0.042), and a lower group fracture rate (0.085/patient cycle compared with 0.239/patient cycle, P = 0.006). The side-effect profile was similar for the two groups; no patient developed microfractures, hip fractures, or blood loss anemia.

Conclusions: Intermittent slow-release sodium fluoride plus continuous calcium citrate, administered for about 2.5 years, inhibits new vertebral fractures, increases the mean spinal bone mass without decreasing the radial shaft bone density, and is safe to use.

Figures

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Figure 1.
Effect of treatment on the mean fasting serum fluoride level.[14]PP

Dashed horizontal lines indicate the “therapeutic window” . Vertical dashed lines indicate the period of fluoride withdrawal. In each cycle (of 14 months), slow-release sodium fluoride or placebo was given during the first 12 months. *  = 0.006; † < 0.001. Values are presented as mean ±SE.

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Figure 2.
Effect of treatment on the L2 to L4 bone mineral content and on the bone density of the femoral neck and the radial shaft.PP

For each cycle, the percentage change of the value from the immediately preceding cycle or baseline was calculated. Thus, a cycle-to-cycle change, rather than a cumulative change, is depicted. The symbol above the bars indicates a significant change from zero, whereas the symbol above the bracket shows a significant change between the placebo and slow-release sodium fluoride (SR-NaF) groups. * = 0.019; † < 0.001. BD = bone density; BMC = bone mineral content.

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Figure 3.
Appearance of new vertebral fractures during placebo administration or slow-release sodium fluoride treatment.

Each line represents a separate patient. The exact location of the circle on the line does not necessarily indicate the actual time of fracture occurrence; rather, it reflects the time of skeletal radiologic examination. closed circles; =a separate new vertebral fracture; open squares = a “cumulative” fracture occurring during two or more cycles, escaping detection on a cycle-to-cycle analysis; numbers designated by E before the line indicate estrogen-treated patients.

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