Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000055404
Ethics application status
Approved
Date submitted
11/01/2007
Date registered
17/01/2007
Date last updated
17/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of calcium and vitamin D supplementation on bone mineral density and bone related chemistry in elderly women
Scientific title
A 5-year randomised controlled trial of the effects of calcium and vitamin D supplementation on bone mineral density and bone related chemistry in elderly ambulant Australian women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly healthy women 1548 0
Condition category
Condition code
Other 1648 1648 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a 5-year randomised, controlled, double-blind study. Participants were randomised to orally receive either 1000 IU ergocalciferol and 1200 mg calcium (Ca) in the form of carbonate (CalD group), 1200 mg Ca and placebo vitamin D (Ca group) per day over the 5 years.
Intervention code [1] 1550 0
Prevention
Comparator / control treatment
Participants were randomised to orally receive placebo Ca and placebo vitamin D (placebo group) per day over the 5 years.
Control group
Placebo

Outcomes
Primary outcome [1] 2273 0
1) Bone structure of hip as measured by Dual Energy X-ray Absorptiometry
Timepoint [1] 2273 0
Measurements were made at baseline, 1, 3 and 5 years.
Primary outcome [2] 2274 0
2) Plasma 25-hydroxy vitamin D
Timepoint [2] 2274 0
Measurements were made at baseline, 1, 3 and 5 years.
Secondary outcome [1] 3979 0
1) Plasma parathyroid hormone
Timepoint [1] 3979 0
Measurements were made at baseline, 1, 3 and 5 years.
Secondary outcome [2] 3980 0
2) Plasma and urinary calcium
Timepoint [2] 3980 0
Measurements were made at baseline, 1, 3 and 5 years.
Secondary outcome [3] 3981 0
3) Biochemical markers of bone turnover
Timepoint [3] 3981 0
Measurements were made at baseline, 1, 3 and 5 years.

Eligibility
Key inclusion criteria
Likely to survive a five-year study.
Minimum age
70 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Receiving bone active agent. There were no other specific exclusions so that the results could be generalised to the whole ambulant population.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject numbers was allocated by personnel having no contact with study participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study subjects, therapists, assessors and data analysts remained blinded to the treatment code until all the data had been entered, evaluated for accuracy and the a-priori hypotheses reviewed.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/07/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1793 0
Charities/Societies/Foundations
Name [1] 1793 0
Healthway Health Promotion Foundation of Western Australia
Country [1] 1793 0
Australia
Funding source category [2] 1794 0
Charities/Societies/Foundations
Name [2] 1794 0
Australasian Menopause Society
Country [2] 1794 0
Australia
Funding source category [3] 1795 0
Government body
Name [3] 1795 0
Australian National Health and Medical Research Council
Country [3] 1795 0
Australia
Primary sponsor type
Individual
Name
A Professor RL Prince
Address
Country
Secondary sponsor category [1] 1613 0
University
Name [1] 1613 0
The University of Western Australia and
Address [1] 1613 0
Country [1] 1613 0
Australia
Secondary sponsor category [2] 1614 0
Hospital
Name [2] 1614 0
the Sir Charles Gairdner Hospital
Address [2] 1614 0
Country [2] 1614 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3350 0
University of Western Australia
Ethics committee address [1] 3350 0
Ethics committee country [1] 3350 0
Australia
Date submitted for ethics approval [1] 3350 0
Approval date [1] 3350 0
21/07/1998
Ethics approval number [1] 3350 0
RA/4/1/1553

Summary
Brief summary
This is a 5-year randomised, double blind, placebo controlled study to evaluate the relative benefits of vitamin D and calcium supplementation and calcium alone compared to placebo on hip bone mineral density and bone related biochemistry in ambulant elderly Western Australian women aged 70-80 years at baseline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27484 0
Address 27484 0
Country 27484 0
Phone 27484 0
Fax 27484 0
Email 27484 0
Contact person for public queries
Name 10739 0
A Professor Richard Prince
Address 10739 0
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 Ave, Nedlands WA 6009
Country 10739 0
Australia
Phone 10739 0
+61 8 93464111
Fax 10739 0
+61 8 93462733
Email 10739 0
[email protected]
Contact person for scientific queries
Name 1667 0
A Professor Richard Prince
Address 1667 0
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 Ave, Nedlands WA 6009
Country 1667 0
Australia
Phone 1667 0
+61 8 93464111
Fax 1667 0
+61 8 93462733
Email 1667 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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