Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000458538
Ethics application status
Approved
Date submitted
26/10/2006
Date registered
31/10/2006
Date last updated
31/10/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of two marketed calcium preparations on reducing serum markers of bone resorption in post menopausal women
Scientific title
Comparison of the effects of two marketed Calcium preparations on reducing serum markers of bone resorption in post menopausal women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers (post menopausal women) 1433 0
Condition category
Condition code
Reproductive Health and Childbirth 1529 1529 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cross over trial using Calsup (calcium carbonate) 1000 mg and Citracal (calcium citrate) 500mg given as single doses orally, one week apart following base line serum tests.
Intervention code [1] 1420 0
Prevention
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2113 0
Auppression of bone resorption markers in serum
Timepoint [1] 2113 0
About 12 hours after each dose
Secondary outcome [1] 3653 0
Serum calcium level
Timepoint [1] 3653 0
Measured as a base line before intervention and then 12 hours after each intervention.
Secondary outcome [2] 3654 0
Serum PTH (parathyroid hormone) level
Timepoint [2] 3654 0
Measured as a base line before intervention and then 12 hours after each intervention.

Eligibility
Key inclusion criteria
Post menopausal (menopause within last 5 years)
Minimum age
50 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. renal failure, intake of calcium supplements, hypercalcaemiaany bone disorder.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomisation table created by a computer software program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
subjects and assesor are blinded
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1668 0
Other
Name [1] 1668 0
Department of Clinical Biochemistry, Institute of Medical and Veterinary Science, Adelaide
Country [1] 1668 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute of Medical and Veterinary Science, Frome road, Adelaide, SA 5000
Address
Country
Australia
Secondary sponsor category [1] 1471 0
Hospital
Name [1] 1471 0
Royal Adelaide Hospital
Address [1] 1471 0
Country [1] 1471 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3109 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 3109 0
Ethics committee country [1] 3109 0
Australia
Date submitted for ethics approval [1] 3109 0
Approval date [1] 3109 0
17/10/2006
Ethics approval number [1] 3109 0
060918

Summary
Brief summary
Calcium supplementation has been shown to reduce the incidence of osteoporosis and related fractures. Currently Calsup (calcium carbonate) is marketed widely in Australia. This study is to compare the effects of Calsup with a newer calcium supplement, Citracal (Calcium citrate) on reducing serum markers of bone resorption. The hypothesis is that citracal may be equally effective in smaller doses and would have less side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27354 0
Address 27354 0
Country 27354 0
Phone 27354 0
Fax 27354 0
Email 27354 0
Contact person for public queries
Name 10609 0
Dr Devika Grasby
Address 10609 0
Department of Clinical Biochemistry
Institute of Medical and Veterinary Science
Frome Road
Adelaide SA 5000
Country 10609 0
Australia
Phone 10609 0
+61 8 82223611
Fax 10609 0
Email 10609 0
[email protected]
Contact person for scientific queries
Name 1537 0
Dr Devika Grasby
Address 1537 0
Department of Clinical Biochemistry
Institute of Medical and Veterinary Science
Frome Road
Adelaide SA 5000
Country 1537 0
Australia
Phone 1537 0
+61 8 82223611
Fax 1537 0
Email 1537 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.