Treatment of primary osteoporosis with fluoride and calcium. Clinical tolerance and fracture occurrence.

Thirty-six patients with primary osteoporosis were treated for up to six years with sodium fluoride, calcium supplements, and, in 24 patients, vitamin D. Major adverse reactions (synovitis, painful plantar fascial syndrome, recurrent vomiting, or anemia) occurred in 15 patients (42%). New vertebral fractures occurred at a rate of 329 fractures per 1,000 years of observation. Almost half of them occurred during the first year of therapy, and they were only one sixth as frequent in 12 patients who had fluoride-induced increased trabeculation on vertebral roentogenograms. Nevertheless, until long-term safety and antifracture efficacy are better established, this regimen should continue to be restricted to investigational use.