Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000640303
Ethics application status
Approved
Date submitted
28/04/2017
Date registered
2/05/2017
Date last updated
2/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perth Longitudinal Study of Aging in Women
Scientific title
A 15-year longitudinal study investigating the role of environmental, anatomical, physiological, metabolic and genetic factors on health outcomes in older women.
Secondary ID [1] 291791 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PLSAW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal 303066 0
Cardiovascular 303067 0
Cognitive 303069 0
Condition category
Condition code
Musculoskeletal 302495 302495 0 0
Osteoporosis
Cardiovascular 302496 302496 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 302497 302497 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Baseline and longitudinal measurements of phenotypic data related to the health of older women including environmental factors (e.g. dietary intakes, physical activity), anatomical measures (e.g. bone mass and structure, anthropometry, body composition, carotid intimal medial thickness), physiological function (e.g. mobility, muscle strength), metabolic function (e.g. ApoE levels, hormonal status, homocysteine, beta-amyloid), and genetic polymorphisms (e.g. estrogen receptor, TGF beta, ApoE 4, Cyp19, MTHFR). The duration of observation was from 1998 to 2013. All participants were initially recruited in 1998 to a 5-year randomised controlled trial, the Calcium Intake Fracture Outcome Study (trial ID ACTRN12615000750583). Participants were then enrolled for an additional 10-year follow-up study (2003-2013).
Intervention code [1] 297904 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301900 0
Fracture-related events assessed by self-reported events and data linkage to hospital admission/discharge records.
Timepoint [1] 301900 0
Data linkage to hospital admission/discharge records is available for each participant from their baseline visit until their date of death or 15 years post baseline visit.
Primary outcome [2] 301938 0
Cardiovascular events assessed by data linkage to hospital admission/discharge and mortality records.
Timepoint [2] 301938 0
Data linkage to hospital admission/discharge and mortality records is available for each participant from their baseline visit until their date of death or 15 years post baseline visit.
Primary outcome [3] 301939 0
Neurocognitive function assessed by Abbreviated Mini Mental Score, California Verbal Learning Test, CAMCOG, and the Mini Mental State Exam.
Timepoint [3] 301939 0
Abbreviated Mini Mental State Score was assessed at baseline, 5, 7, 10 and 12 years. The California Verbal Learning Test and CAMCOG was assessed at 3 and 4 years. The Mini Mental State Exam was assessed at 3, 4, 10 and 12 years.
Secondary outcome [1] 334243 0
Cancer-related events assessed by data linkage to hospital admission/discharge and mortality records.
Timepoint [1] 334243 0
Data linkage to hospital admission/discharge records is available for each participant from their baseline visit until their date of death or 15 years post baseline visit.
Secondary outcome [2] 334301 0
Renal disease-related events assessed by data linkage to hospital admission/discharge and mortality records.
Timepoint [2] 334301 0
Data linkage to hospital admission/discharge records is available for each participant from their baseline visit until their date of death or 15 years post baseline visit.

Eligibility
Key inclusion criteria
The key inclusion criteria was age greater than 70 years and less than or equal to 85 years, and likelihood to survive a 5-year study. This key inclusion criteria was for all participants previously enrolled in the Calcium Intake Fracture Outcome Study (trial ID ACTRN12615000750583).
Minimum age
70 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Receipt of a bone active agent. This exclusion criteria was for all participants previously enrolled in the Calcium Intake Fracture Outcome Study (trial ID ACTRN12615000750583).

There were no other specific exclusions so that the results could be generalized to the entire ambulant population.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/02/1998
Date of last participant enrolment
Anticipated
Actual
21/12/1998
Date of last data collection
Anticipated
Actual
31/12/2013
Sample size
Target
1500
Accrual to date
Final
1500
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 296295 0
Government body
Name [1] 296295 0
National Health and Medical Research Council of Australia
Country [1] 296295 0
Australia
Funding source category [2] 296297 0
Government body
Name [2] 296297 0
Healthway
Country [2] 296297 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy Crawley, WA Australia 6009
Country
Australia
Secondary sponsor category [1] 295220 0
None
Name [1] 295220 0
Address [1] 295220 0
Country [1] 295220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297526 0
The Human Rights Committee of the University of Western Australia, Perth, Australia
Ethics committee address [1] 297526 0
Ethics committee country [1] 297526 0
Australia
Date submitted for ethics approval [1] 297526 0
Approval date [1] 297526 0
28/11/1997
Ethics approval number [1] 297526 0
05/06/004/H50

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74330 0
Prof Richard Prince
Address 74330 0
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Country 74330 0
Australia
Phone 74330 0
+61 8 6151 0830
Fax 74330 0
Email 74330 0
[email protected]
Contact person for public queries
Name 74331 0
Richard Prince
Address 74331 0
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Country 74331 0
Australia
Phone 74331 0
+61 8 6151 0830
Fax 74331 0
Email 74331 0
[email protected]
Contact person for scientific queries
Name 74332 0
Richard Prince
Address 74332 0
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth, Australia
Country 74332 0
Australia
Phone 74332 0
+61 8 6151 0830
Fax 74332 0
Email 74332 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
SourceTitleYear of PublicationDOI
EmbaseAssociation of dietary nitrate with atherosclerotic vascular disease mortality: A prospective cohort study of older adult women.2017https://dx.doi.org/10.3945/ajcn.116.146761
EmbaseCruciferous and allium vegetable intakes are inversely associated with 15-Year atherosclerotic vascular disease deaths in older adult women.2017https://dx.doi.org/10.1161/JAHA.117.006558
EmbaseVegetable diversity, injurious falls, and fracture risk in older women: A prospective cohort study.2018https://dx.doi.org/10.3390/nu10081081
EmbaseVegetable diversity in relation with subclinical atherosclerosis and 15-year atherosclerotic vascular disease deaths in older adult women.2020https://dx.doi.org/10.1007/s00394-019-01902-z
EmbaseAbdominal aortic calcification, cardiac troponin I and atherosclerotic vascular disease mortality in older women.2022https://dx.doi.org/10.1136/heartjnl-2021-319879
EmbaseCardiovascular disease, muscle function, and long-term falls risk: The Perth Longitudinal Study of Ageing Women.2023https://dx.doi.org/10.1016/j.archger.2022.104911
N.B. These documents automatically identified may not have been verified by the study sponsor.