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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
001486
ACTR Number:
ACTRN12606000331538
Trial Status:
Registered
Date Submitted:
25/07/2006
Date Registered:
3/08/2006
Page 1
Public title:
Effects of vitamin D and calcium on bone and falls in an elderly population of Australian women selected for their history of falling
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ANZCTR registration title:
A randomised controlled study to evaluate the effects of vitamin D and calcium on lowering fall risk and improving bone structure in an elderly population of Australian women with low vitamin D status and a history of falling
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Secondary ID:
UTN:
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Page 2
Health condition(s) or problem(s) studied:
Falls and bone structure in elderly Australian women
Condition category:
Condition code:
Injuries and Accidents
Other injuries and accidents
Page 3
Description of intervention(s) / exposure:
A one-year randomised double-blind clinical trial of oral supplementation of 1000 International Units of ergocalciferol per day versus placebo. All subjects received 1000 mg of calcium per day orally as calcium citrate.
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Intervention code:
Prevention
Comparator / control treatment:
Placebo
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Control group:
Placebo
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Page 4
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.
Page 5
Key inclusion criteria:
A history of falling in the past 12 months; plasma 25-hydroxy vitamin D concentration less than 60 nmol/L.
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Minimum Age:
70
Years
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Maximum Age:
90
Years
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Gender:
Females
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Healthy volunteers?
No
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Key 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).
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Page 6
Study type:
Interventional
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Purpose of the study:
Prevention
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Allocation to intervention:
Randomised controlled trial
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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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Page 7
Phase
Phase 2 / Phase 3
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Anticipated or actual date of first participant enrolement:
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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Page 8
Funding source:
Government funding body e.g. Australian Research Council
Name:
Australian National Health and Medical Research Council
Address:
Country:
Australia
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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Address:
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Country:
Australia
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Secondary sponsor:
University
Name:
The University of Western Australia
Address:
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
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Reason:
Ethics Committee name:
Sir Charles Gairdner Hospita
Address:
Country:
Australia
Date of approval:
HREC Number:
2002-041
Countries of recruitment:
Australia
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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Presentations / publication list:
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Page 10
Contact person for public queries
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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Country:
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
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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Country:
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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