Effects of vitamin D and calcium on bone and falls in an elderly population of Australian women selected for their history of falling
Phase 2
Completed
- Conditions
- Falls and bone structure in elderly Australian womenInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12606000331538
- Lead Sponsor
- Australian National Health and Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 294
Inclusion Criteria
A history of falling in the past 12 months; plasma 25-hydroxy vitamin D concentration less than 60 nmol/L.
Exclusion Criteria
Fracture in the past 6 months; receiving bone active agents including vitamin D; a mini mental state score less than 24; bone mineral density Z score of less than -2.0; medical conditions or disorders that influence bone mineral metabolism or substantially impair balance; significant illness; laboratory evidence of renal insufficiency (creatinine more than twofold of the normal value).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Falls subjects have during the 1 year follow-up.[Fall data are collected every 6 weeks via telephone interview or clinic visit during the 1 year follow-up.];2. Bone structure of total body, hip and forearm as measured by Dual Energy X-ray Absorptiometry and peripheral Quantitative Computed Tomography and Instant Vertebral Assessment.[Collected at baseline and 12 months.]
- Secondary Outcome Measures
Name Time Method 1. Falls risk assessment testing using the Lord falls assessment testing approach. A test of vision (edge contrast sensitivity and visual acuity), peripheral sensation, lower limb strength, and postural sway. [Data are collected at baseline, 6 and 12 months.];2. Functionality using the Barthel and Timed Up and Go Test.[Data are collected at baseline, 6 and 12 months.];3. Biochemical markers of bone resorption and bone formation.[Data are collected at baseline, 6 and 12 months.];4. Calcium related biochemistry and gut calcium absorption. [Data are collected at baseline, 6 and 12 months.];5. Quality of life by SF-36.[Data are collected at baseline, 6 and 12 months.];6. Safety data including side effect data and all clinical event data. [Data are collected at baseline, 6 and 12 months.]