Monofluorophosphate increases lumbar bone density in osteopenic patients: a double-masked randomized study.
To assess the efficacy of combined sodium monofluorophosphate and calcium therapy (FC) in increasing lumbar bone mineral density (BMD) in patients with low bone mass, we conducted a prospective double-masked randomized study in 94 patients aged 50-70 years. Patients were selected on the basis of a lumbar BMD at least 2 standard deviations (SD) below the young adult mean (T-score) but without evidence of previous vertebral fracture (severe osteopenia). They were randomly assigned to receive for 2 years, twice a day, either FC (13.2 mg F-, i.e. 100 mg sodium monofluorophosphate, and 500 mg Ca2+) or C (500 mg Ca2+). Vertebral BMD was measured by dual photon absorptiometry from L2 to L4. Comparison at final assessment in the 76 eligible patients (Student's t-test) showed a statistically significant difference between the two groups in the mean BMD increase in favour of FC. Furthermore, Student's t-test showed a significantly greater increase in lumbar BMD in FC-treated patients at 1 year, at 18 months and after 2 years (mean increase of 7.1%/year). These results were confirmed by ANOVA at 1 year, at 18 months and after 2 years of treatment. Of the FC-treated patients, 71.4% were considered to have responded (i.e. they showed an increase in lumbar BMD of more than 0.034 g/cm2). The dosage of 26.4 mg fluoride ion/day (i.e. 200 mg monofluorophosphate/day) therefore appears to be safe and to increase the BMD effectively in patients with low bone mass prior to vertebral fracture.
Sebert
J L
JL
CHRU Amiens, France.
Richard
P
P
Mennecier
I
I
Bisset
J P
JP
Loeb
G
G
D015502:Absorptiometry, Photon; D000368:Aged; D000704:Analysis of Variance; D015519:Bone Density / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides / Q000009:adverse effects / Q000627:therapeutic use*; D050723:Fractures, Bone / Q000188:drug therapy / Q000503:physiopathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000503:physiopathology; D010710:Phosphates / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
D010710:Phosphates; C012980:fluorophosphate; D005459:Fluorides