The effect of low dose fluoride on bone
- Conditions
- OsteoporosisMusculoskeletal - Osteoporosis
- Registration Number
- ACTRN12607000128493
- Lead Sponsor
- Associate Professor Andrew Grey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 180
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in lumbar spine bone mineral density (BMD[At 1 year]
- Secondary Outcome Measures
Name Time Method Change in hip BMD [At 1 year];Change in forearm BMD[At 1 year];Change in biochemical markers of bone turnover [At 1 year];Bone histology [At 1 year]