A new fluoride preparation for the prevention of postmenopausal osteoporosis: calcium monofluorophosphate.
Fifty-six postmenopausal women aged 52.4 +/- 6.7 years (SD) were treated for 12 months with L-glutamine calcium monofluorophosphate. Each patient received four tablets/day, providing a total dose of 20 mg of fluoride and 600 mg of elemental calcium. Bone mineral density was measured 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 hydroxyproline and calcium, were also assayed. Results were compared with a control group of 50 untreated postmenopausal women with similar clinical 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 controls (p < 0.01). After 12 months no significant further increase in bone mineral density was detected. In the control group, a significant decrease of bone mineral density was observed at this time (p < 0.01). After 6 months, serum osteocalcin levels were significantly increased in the treated group (p < 0.01 vs. basal and controls). The other biochemical parameters did not show any significant variations. After 12 months, all the biochemical parameters evaluated, with the exception of serum alkaline phosphatase, were significantly different in comparison with 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 because of gastrointestinal complaints.(ABSTRACT TRUNCATED AT 250 WORDS)
Affinito
P
P
Department of Obstetrics and Gynecology, School of Medicine, University Federico II, Naples, Italy.
Di Carlo
C
C
Primizia
M
M
Petrillo
G
G
Napolitano
V
V
Tremolaterra
F
F
Nappi
C
C
D000469:Alkaline Phosphatase / Q000097:blood; D015519:Bone Density; D002118:Calcium / Q000008:administration & dosage / Q000652:urine; D005260:Female; D005459:Fluorides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006909:Hydroxyproline / Q000652:urine; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D010710:Phosphates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D010710:Phosphates; D015675:Osteocalcin; C012980:fluorophosphate; D000469:Alkaline Phosphatase; D005459:Fluorides; D006909:Hydroxyproline; D002118:Calcium