Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000242628
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
31/08/2005
Date last updated
26/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Calcium Fracture Study
Scientific title
Anti-fracture efficacy of calcium supplementation in normal postmenopausal women
Secondary ID [1] 284666 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal fractures 328 0
Condition category
Condition code
Reproductive Health and Childbirth 377 377 0 0
Menstruation and menopause
Other 378 378 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily 1g calcium (as the citrate) over 5 years.
Intervention code [1] 239 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 436 0
Time to first clinical fracture
Timepoint [1] 436 0
5 years
Secondary outcome [1] 961 0
Total vertebral fractures.
Timepoint [1] 961 0
5 years
Secondary outcome [2] 962 0
Hip fractures.
Timepoint [2] 962 0
5 years
Secondary outcome [3] 963 0
Forearm fractures.
Timepoint [3] 963 0
5 years
Secondary outcome [4] 964 0
Osteoporotic fractures.
Timepoint [4] 964 0
5 years
Secondary outcome [5] 965 0
The difference between fall frequency over 5 years in the calcium-treated group compared to the incidence in the control group.
Timepoint [5] 965 0
5 years

Eligibility
Key inclusion criteria
Females >5 years postmenopausal and aged >55 years with life-expectancy >5 years.
Minimum age
55 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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
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 allocated by personnel based in a different building and having no contact with study subjects
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers with minimisation algorithm for thiazide diuretic use and previous history of fracture
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/1998
Actual
17/03/1998
Date of last participant enrolment
Anticipated
Actual
9/08/2000
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment outside Australia
Country [1] 145 0
New Zealand
State/province [1] 145 0

Funding & Sponsors
Funding source category [1] 433 0
Government body
Name [1] 433 0
Health Research Council of New Zealand
Country [1] 433 0
New Zealand
Primary sponsor type
Individual
Name
Professor I Reid
Address
Bone and Joint Group,
University of Auckland,
Private Bag 92019
Auckland, 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 351 0
University
Name [1] 351 0
University of Auckland Bone Research Group
Address [1] 351 0
Private Bag 92019, Auckland 1142, New Zealand
Country [1] 351 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1402 0
Auckland University
Ethics committee address [1] 1402 0
Ethics committee country [1] 1402 0
New Zealand
Date submitted for ethics approval [1] 1402 0
Approval date [1] 1402 0
Ethics approval number [1] 1402 0

Summary
Brief summary
This is a 5 year study designed to determine whether a 1g calcium supplement daily prevents symptomatic fractures.
Trial website
Trial related presentations / publications
Reid IR, Mason B, Horne A, Ames R, Reid HE, Bava U, Bolland MJ, Gamble GD. Randomized controlled trial of calcium in healthy older women. Am J Med 2006;119:777-85.

Bolland MJ, Barber PA, Doughty RN, Mason B, Horne A, Ames R, Gamble GD, Grey A, Reid IR. Vascular events in healthy older women receiving calcium supplementation: randomised controlled trial. BMJ 2008;336:262-6.
Public notes

Contacts
Principal investigator
Name 36256 0
Prof Ian Reid
Address 36256 0
Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
Private Bag 92 019,
Auckland 1142
Country 36256 0
New Zealand
Phone 36256 0
6493737599
Fax 36256 0
Email 36256 0
[email protected]
Contact person for public queries
Name 9428 0
Ms Barbara Mason
Address 9428 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 9428 0
New Zealand
Phone 9428 0
+64 9 3078970
Fax 9428 0
+64 9 3737677
Email 9428 0
[email protected]
Contact person for scientific queries
Name 356 0
Prof Professor Ian Reid
Address 356 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 356 0
New Zealand
Phone 356 0
+64 9 3737599
Fax 356 0
+64 9 3737677
Email 356 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
No additional documents have been identified.