Calcium Fracture Study
- Conditions
- Postmenopausal fracturesReproductive Health and Childbirth - Menstruation and menopauseOther - Fractures
- Registration Number
- ACTRN12605000242628
- Lead Sponsor
- Professor I Reid
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1500
Females >5 years postmenopausal and aged >55 years with life-expectancy >5 years.
Renal impairment (serum creatinine > 0.2mmol/l), Untreated hypo- or hyperthyroidism, Active liver disease, Serum 25-hydroxyvitamin D < 14 ng/ml, Concurrent major systemic disease, including malignancy, Metabolic bone disease, Regular use of hormone replacement therapy within the previous 1 year, Regular use of sodium fluoride in a dose greater than or equal to 20mg per day in the previous 1 year, Regular use of anabolic steroid preparations in the previous 1 year, Treatment with bisphosphonates in the previous 1 year, Current treatment with glucocorticoid drugs, Calciferol supplements in doses >1000 iu/day or 50,000 iu/month, Lumbar spine bone density < mean-2.0 SD for age-appropriate data.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first clinical fracture[5 years]
- Secondary Outcome Measures
Name Time Method Total vertebral fractures.[5 years];Hip fractures.[5 years];Forearm fractures.[5 years];Osteoporotic fractures.[5 years];The difference between fall frequency over 5 years in the calcium-treated group compared to the incidence in the control group.[5 years]