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Trial registered on ANZCTR


Trial ID
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 433 0
PO Box 5541, Wellesley Street, Auckland 1141, 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
i.reid@auckland.ac.nz
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
b.mason@auckland.ac.nz
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
i.reid@auckland.ac.nz