The effect of low dose fluoride on bone
A randomized, double-blind, placebo-controlled, dose-finding study of the effects of sodium fluoride on bone turnover, bone density and bone histology in osteopenic post menopausal women.
Associate Professor Andrew Grey
180 participants
Jun 30, 2009
Interventional
Conditions
Summary
This is a 1 year study designed to investigate the effects of low-dose fluoride therapy on bone. We are testing whether doses of fluoride that are lower than have been studied in previous trials might have positive effects on bone density and metabolism, without affecting bone quality. 180 postmenopausal women with mild bone thinning will be randomly (by chance) allocated to receive placebo (inactive) treatment or one of 3 low doses of fluoride (2.5, 5 or 10 mg/day). Each participant will be seen on 5 occasions during the study, for assessment of bone density and bone-related biochemistry (blood and urine tests). Bone biopsy from the back of the pelvis will be sought from 6-10 participants in each treatment group at the end of the study - this is a voluntary procedure.
Eligibility
Plain Language Summary
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Interventions
Subjects randomized to placebo or 1 of 3 treatment groups: sodium fluoride 2.5mg daily, per oral, 5mg daily per oral, 10mg daily per oral, for 1 year. No dosage increments Active and placebo tablets are identical in appearance
Locations(1)
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ACTRN12607000128493