A NEW FLUORIDE PREPARATION FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS - CALCIUM MONOFLUOROPHOSPHATE

Fifty-six postmenopausal women aged 52.4 +/- 6.7 years (SD) were treat ed for 12 months with L-glutamine calcium monofluorophosphate. Each pa tient received four tablets/day, providing a total dose of 20 mg of fl uoride and 600 mg of elemental calcium. Bone mineral density was measu red at baseline and after 6 and 12 months of treatment by dual photon absorptiometry of the distal forearm. At these times, serum levels of alkaline phosphatase and osteocalcin, and urinary concentrations of hy droxyproline and calcium, were also assayed. Results were compared wit h a control group of 50 untreated postmenopausal women with similar cl inical characteristics. Forty-nine patients completed the study. Bone mineral density in the treated patients showed a significant increase after 6 months in comparison with both baseline (p < 0.01) and control s (p < 0.01). After 12 months no significant further increase in bone mineral density was detected. In the control group, a significant decr ease of bone mineral density was observed at this time (p < 0.01). Aft er 6 months, serum osteocalcin levels were significantly increased in the treated group (p < 0.01 vs. basal and controls). The other biochem ical parameters did not show any significant variations. After 12 mont hs, all the biochemical parameters evaluated, with the exception of se rum alkaline phosphatase, were significantly different in comparison w ith the control group (p < 0.01). Osteocalcin levels also increased in comparison with the basal value (p < 0.01). Adverse effects were mild . However, seven patients stopped the treatment before the 6th month b ecause of gastrointestinal complaints. Our results seem to show that a dministration of calcium monofluorophosphate is an effective and safe treatment in the prevention of postmenopausal bone loss.