Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001040055
Ethics application status
Approved
Date submitted
22/01/2010
Date registered
25/11/2010
Date last updated
25/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relationship between bone loss and dietary calcium intake
Scientific title
Correlation between annual percentage bone loss and dietary calcium intake in post menopausal women
Secondary ID [1] 253159 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 256653 0
Condition category
Condition code
Musculoskeletal 256814 256814 0 0
Osteoporosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention
Dietary calcium intake ascertained by a food frequency questionnaire will be correlated with percentage bone loss as determined by bone density scans done 6 monthly for a period of 2 years
Intervention code [1] 255890 0
Not applicable
Comparator / control treatment
Not applicable, observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257677 0
Percentage bone loss as detected by bone density scans 6 monthly
Timepoint [1] 257677 0
Baseline, 6 months, 12 months, 18 months and 2 years
Secondary outcome [1] 262993 0
incident fractures by questionniare and followup via telephone
Timepoint [1] 262993 0
annually for 2 years

Eligibility
Key inclusion criteria
Post menopausal women
Minimum age
50 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hormone replacement therapy
anti resorptive therapy
disorders of calcium metabolism
advanced renal disease
malignancy

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256377 0
University
Name [1] 256377 0
Adelaide University
Country [1] 256377 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Centre of Clinical Research Excellence (CCRE) in
Nutritional Physiology, Interventions and Outcomes
Discipline of Medicine
The University of Adelaide
Level 6 Eleanor Harrald Building
Royal Adelaide Hospital
Frome Road
S.A. 5005
Country
Australia
Secondary sponsor category [1] 251689 0
Hospital
Name [1] 251689 0
Royal Adelaide Hospital
Address [1] 251689 0
Endocrine unit
RAH
North Terrace
Adelaide
SA 5050
Country [1] 251689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258442 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 258442 0
Research Ethics Committee
Royal Adelaide Hosptial
North Terrace
Adelaide
SA 5050
Ethics committee country [1] 258442 0
Australia
Date submitted for ethics approval [1] 258442 0
Approval date [1] 258442 0
29/09/2009
Ethics approval number [1] 258442 0
090715

Summary
Brief summary
Bone loss occurs at an accelerated rate in women after the menopause. This has been attributed to reduced calcium absorption in the gut and increase excretion of calcium in the urine. This bone loss may be greater in those on low calcium diets compared with those on high calcium diets. This has been shown in animals and some human studies have been able to link low lumbar spine density to low calcium diets.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30752 0
Address 30752 0
Country 30752 0
Phone 30752 0
Fax 30752 0
Email 30752 0
Contact person for public queries
Name 13999 0
Dr Devika Thomas
Address 13999 0
Chemical Pathology
Level 2, Institute of Medical and Veterinary Science (IMVS)
SA Pathology
Frome road
Adelaide
SA 5050
Country 13999 0
Australia
Phone 13999 0
+61 08 82223611
Fax 13999 0
+61 08 82223518
Email 13999 0
[email protected]
Contact person for scientific queries
Name 4927 0
Dr Devika Thomas
Address 4927 0
Chemical Pathology
Level 2, Institute of Medical and Veterinary Science (IMVS)
SA Pathology
Frome road
Adelaide
SA 5050
Country 4927 0
Australia
Phone 4927 0
+61 08 82223611
Fax 4927 0
+61 08 82223518
Email 4927 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.