Extended treatment of primary osteoporosis by sodium fluoride combined with 25 hydroxycholecalciferol.

Nineteen patients suffering from primary osteoporosis, all having at least one vertebral collapse, initially received 50 mg of sodium fluoride alone per day for 6-18 months. Subsequently fluoride was associated with 25-50 micrograms of 25 OH cholecalciferol (calcifediol) per day for 6-18 months in 12 of these patients and 9 were treated for 31-58 months. As control group, 9 patients were given placebo for 6-18 months. The effect of the treatment was assessed by three methods: 1) the metacarpal index (MI) determined by radiogrammetry, 2) the calcium content of the hand bone (Ca) measured by local neutron activation, 3) the iliac bone histomorphometry. MI and (Ca) did not change significantly at any time in any group. In each group there was a significant increase in trabecular bone volume, osteoid volume, osteoid surfaces and a significant decrease in mineralization fronts. On the other hand, the changes in osteoblastic surfaces, osteoclastic surfaces, number of osteoclasts/mm2 were not significant in any group. No change was observed in the placebo group. These data suggest that the increase in the trabecular volume of fluorided bone is mainly due to the increase in osteoid which itself is due to a bone mineralization defect despite the association of calcifediol. This is probably one of the reasons why (Ca) does not change significantly.

RCT Entities:   Population Interventions Outcomes