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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000128493

Acronym

FEAST

Enrollment

180

Registered

2007-02-14

Start date

2009-06-30

Completion date

2010-03-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

Postmenopausal 5 yrs or more (menopause defined as at least 12 months since last period in woman aged > 45 yrs with intact uterus, or serum follicle stimluating hormone (FSH) > 50 IU/l in younger or hysterectomized woman)- Bone density T score less than -1.0 and greater than -2.5 at L1-L4 or Total Hip.- BMD T-score <-2.5 at lumbar spine or total hip, but participant is not a suitable candidate for, or has decided against taking, osteoporosis therapy

Exclusion criteria

Medical Conditions- renal impairment (serum creatinine 120 µmol/L).- congestive heart failure- chronic liver disease.- untreated hypothyroidism or hyperthyroidism.- concurrent major systemic illness, including malignancy.- active major gastrointestinal disease.- metabolic bone diseases, or serum alkaline phosphatase (ALP) > 2x normal limit.- primary hyperparathyroidism. - Vitamin D insufficiency (25 hydroxyvitamin D [OHD] < 50nmol/L)Medications- use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months- use of aminobisphosphonates within the past 2 years, or etidronate within the past 1 year- use of hormone replacement therapy within the last 12 months- use of other medication known to cause osteoporosis or interfere with bone metabolism.

Outcome results