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| Primary outcome 1: | 1. Falls subjects have during the 1 year follow-up. |
| Timepoint: | Fall data are collected every 6 weeks via telephone interview or clinic visit during the 1 year follow-up. |
| Primary outcome 2: | 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. |
| Timepoint: | Collected at baseline and 12 months. |
| Secondary outcome 1: | 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. |
| Timepoint: | Data are collected at baseline, 6 and 12 months. |
| Secondary outcome 2: | 2. Functionality using the Barthel and Timed Up and Go Test. |
| Timepoint: | Data are collected at baseline, 6 and 12 months. |
| Secondary outcome 3: | 3. Biochemical markers of bone resorption and bone formation. |
| Timepoint: | Data are collected at baseline, 6 and 12 months. |
| Secondary outcome 4: | 4. Calcium related biochemistry and gut calcium absorption. |
| Timepoint: | Data are collected at baseline, 6 and 12 months. |
| Secondary outcome 5: | 5. Quality of life by SF-36. |
| Timepoint: | Data are collected at baseline, 6 and 12 months. |
| Secondary outcome 6: | 6. Safety data including side effect data and all clinical event data. |
| Timepoint: | Data are collected at baseline, 6 and 12 months. |
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Key inclusion criteria:
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A history of falling in the past 12 months; plasma 25-hydroxy vitamin D concentration less than 60 nmol/L. |
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Reason:
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Minimum Age:
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70
Years
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Maximum Age:
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90
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Gender:
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Females |
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Healthy volunteers?
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No |
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Key exclusion criteria:
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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). |
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Study type: |
Interventional |
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Reason:
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Purpose of the study: |
Prevention |
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Allocation to intervention: |
Randomised controlled trial |
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Reason:
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): |
Subject numbers allocated by personnel having no contact with study subjects. |
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): |
Computer-generated block randomisation sequence. |
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Masking / blinding: |
Blinded (masking used) |
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Who is/are masked/blinded: |
The people receiving the treatment/s
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Assignment: |
Parallel |
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Other design features (specify): |
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Type of endpoint(s): |
Safety/efficacy |
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Phase |
Phase 2 / Phase 3 |
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Anticipated or actual start date: |
1/04/2003 |
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Target sample size: |
294 |
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Recruitment status: |
Closed: follow-up complete |
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| Funding source: | Government funding body e.g. Australian Research Council |
| Name: | Australian National Health and Medical Research Council |
| Address: | |
| Country: | Australia |
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Primary sponsor: |
Government funding body e.g. Department of Health |
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Name: |
Australian National Health and Medical Research Council |
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Australia |
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| Secondary sponsor: | University |
| Name: | The University of Western Australia |
| Address: | |
| Country: | Australia |
| Other collaborator: | |
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Has the study received approval from at least one ethics committee? |
Yes |
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Reason:
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| Ethics Committee name: | Sir Charles Gairdner Hospita |
| Address: | |
| Country: | Australia |
| Date of approval: | |
| HREC Number: | 2002-041 |
| Countries of recruitment: | Australia |
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Brief summary: |
This is a one-year randomised, double blind, placebo controlled study designed to evaluate the effects of ergocalciferol and calcium supplementation compared to calcium alone on fall risk and bone structure in elderly women with a plasma 25-hydroxy vitamin D level below 60 nmol/L and a history of falling in the past 12 months. Subjects were randomised by personnel having no contact with study subjects. The study subjects and the study staff remained blinded to the treatment codes during the 1 year study. |
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Trial website: |
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Contact person for public queries
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Name: |
Associate Professor Richard Prince |
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Address: |
Bone and Calcium Research Group
School of Medicine and Pharmacology
University of Western Australia
Department of Endocrinology and Diabetes
1st Floor C Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009 |
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Australia |
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Tel: |
+61 8 93462847 |
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Fax: |
+61 8 93463221 |
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Email: |
rlprince@cyllene.uwa.edu.au |
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Contact person for scientific queries |
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Name: |
Associate Professor Richard Prince |
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Address: |
Bone and Calcium Research Group
School of Medicine and Pharmacology
University of Western Australia
Department of Endocrinology and Diabetes
1st Floor C Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009 |
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Australia |
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+61 8 93462847 |
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+61 8 93463221 |
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rlprince@cyllene.uwa.edu.au |
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