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Safe and Effective Treatment of Osteoporosis With Intermittent Slow Release Sodium Fluoride: Augmentation of Vertebral Bone Mass and Inhibition of Fractures^*

Center for Mineral Metabolism and Clinical Research and Division of Orthopedic Surgery, Department of Surgery, University of Texas Southwestern Medical Center Dallas, Texas 75235

Address all correspondence and requests for reprints to: Dr. Charles Y. C. Pak, Department of Internal Medicine, University of Texas Southwestern Medical Center, 5323 Harry Hires Boulevard, Dallas, Texas 75235.

The value of intermittent slow release sodium fluoride treatment in the management of osteoporosis was studied by a comprehensive metabolic and clinical assessment during a long term trial. Its effect was compared with that of a large dose of 1,25-dihydroxyvitamin D [1,25-(OH)₂D] given for a short period preceding each fluoride treatment period in another group of randomly selected patients. The 24 patients in group I (3 idiopathic and 21 postmenopausal) received cyclic treatment in repeated 5-month cycles; each cycle was initiated by 1,25- (OH)₂D (2 µg/day) for 2 weeks, followed for 3 months by sodium fluoride (slow release, 25 mg twice daily) with 25-hydroxyvitamin D (50 µg twice weekly) and calcium supplements (to bring total calcium intake to 1500 mg/day), and was concluded by 6 weeks of 25-hydroxyvitamin D and calcium supplementation without sodium fluoride. The 21 patients in group II (3 idiopathic and 18 postmenopausal) received the same treatment, except for the omission of 1,25-(OH)₂D.

In both groups, the serum fluoride level was maintained within 5–10 µmol/L (95–190 ng/mL) during fluoride treatment, and serum osteocalcin concentrations correlated positively with the duration of treatment. However, vertebral bone mineralcontent (L2–L4) did not increase significantly in group I, whereas it rose significantly in group II (fractional change, +0.031/2.4 yr in group I vs. +0.118/2.9 yr in group II; P < 0.005). Although bone histomorphometric analyses disclosed overall improvement in both groups, only group II had significantincreases in the mineral apposition rate [0.5 ± 0.2 (±SE) to 1.4 ± 0.2 µm/day; P < 0.05] and the adjusted apposition rate (0.2 ± 0.1 to 0.7 ± 0.1 µm/day; P = 0.04). The vertebral fracture rate significantly declined in both groups, but more so in group II. Excluding the first year of treatment, the fracture rate during treatment in group II of 0.03/patient yr was significantly lower than that of 0.28/patient yr in group I (P < 0.05). The treatment was well tolerated in both groups; only 16% of patients had either gastrointestinal or rheumatic complications.

We conclude that intermittent sodium fluoride treatment without 1,25-(OH)₂D provides safe and effective treatment of osteoporosis, marked by formation of new adequately mineralized bone, a rise in vertebral bone mass, and reduced frequency of vertebral fractures. The addition of 1,25-(OH)₂D treatment before initiation of each fluoride phase yielded a less favorable response (J Clin Endocrirwl Metab 68: 150,1989)

^* This work was supported by USPHS Grant R01-AR16061 and GCRC Grant M01-RR00633.

Received June 27, 1988.

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