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Trial registered on ANZCTR


Registration number
ACTRN12620000161921
Ethics application status
Approved
Date submitted
31/01/2020
Date registered
14/02/2020
Date last updated
16/09/2022
Date data sharing statement initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Why Indigenous Australians Fall and Fracture: Study of Indigenous Muscle and Bone Ageing (SIMBA)
Scientific title
Why Indigenous Australians Fall and Fracture: Study of Indigenous Muscle and Bone Ageing (SIMBA)
Secondary ID [1] 300307 0
nil
Universal Trial Number (UTN)
Trial acronym
SIMBA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoporosis 315908 0
sarcopenia 315910 0
Condition category
Condition code
Musculoskeletal 314179 314179 0 0
Osteoporosis
Diet and Nutrition 314180 314180 0 0
Obesity
Musculoskeletal 314181 314181 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective longitudinal observational study, recruiting Aboriginal and Torres Strait Islander Australians (Indigenous Australians) residing in the Melbourne region (Australia), with a total of 298 adults. Stratified sampling by age and sex will be used to ensure equal distribution of men and women across the four age-bands, namely 35-44, 45-54, 55-64, 65+ years. Recruitment will include: referrals from clinicians at Monash Health; emails and speaking engagements with community groups, including yarning circles, Elders social gatherings, and various committee meetings, by invitation and support from Monash University Elder in residence; advertising posters displayed at various Victorian Aboriginal Health Services and Aboriginal Gathering Places; networking and communicating with various Indigenous communities with the support of the Monash Indigenous Engagement Unit and the Bunurong Health Service.

Participants will come into Monash Medical Centre for a study visit at baseline, follow-up 1 and follow-up 2. The interval between study visits will be 12-15 months.

Data collected will include:
- Questionnaires: demographics, reproductive history, sarcopenia and quality of life (SarQoL), Osteoporosis Knowledge Assessment Tool, Osteoporosis Health Belief Scale, and the International Physical Activity Questionnaire (IPAQ) - Short Form.
- Anthropometry: height, weight, sidedness, blood pressure and pulse.
- Bloods: clinical indicators of diabetes, cardiovascular disease and chronic kidney disease will be measured.
- Food frequency questionnaire (FFQ) from the Victorian Cancer Council (DQES)
- Bone health: dual energy x-ray absorptiometry (DXA), high resolution peripheral quantitative computed tomography (HR-pQCT) and pQCT
- Body composition: DXA and pQCT
- Muscle strength: hand grip strength, jumping mechanography and short physical performance battery (SPPB)

Each study visit will take approximately 1.5-2hrs.
Intervention code [1] 316582 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322703 0
Within individual change in areal bone mineral density (aBMD) at the total hip, femoral neck and lumbar spine assessed by Hologic Horizon A dual energy x-ray absorptiometry (DXA)
Timepoint [1] 322703 0
Baseline, follow-up 1 and 2
Primary outcome [2] 322704 0
Within individual change in cortical and trabecular bone mineral density at the epiphysis and diaphysis of the radius and tibia using HRpQCT (Scanco, XtremeCT-II) and pQCT (Stratec)
Timepoint [2] 322704 0
Baseline, follow-up 1 and 2
Secondary outcome [1] 379358 0
Whole body fat mass and lean mass assessed by Hologic Horizon A dual energy x-ray absorptiometry (DXA)
Timepoint [1] 379358 0
At baseline, follow-up 1 and 2
Secondary outcome [2] 379359 0
Peak muscle force and power in the legs assessed by the Leonardo ground reaction force platform
Timepoint [2] 379359 0
At baseline, follow-up 1 and 2
Secondary outcome [3] 379360 0
Sarcopenia and quality of life status as assessed by the Sarcopenia and Quality of Life (SarQoL) questionnaire
Timepoint [3] 379360 0
At baseline, follow-up 1 and 2
Secondary outcome [4] 379361 0
Osteoporosis knowledge will be assessed using a modified Osteoporosis Knowledge Assessment Tool (OKAT) questionnaire
Timepoint [4] 379361 0
At baseline and follow-up 2
Secondary outcome [5] 379362 0
Beliefs about osteoporosis will be determined using the Osteoporosis Health Belief Scale questionnaire
Timepoint [5] 379362 0
At baseline and follow-up 2
Secondary outcome [6] 379363 0
Differences in hand grip strength will be determined using a Jamar hand dynamometer
Timepoint [6] 379363 0
At baseline, follow-up 1 and 2
Secondary outcome [7] 379364 0
Differences in physical activity will be determined using the International Physical Activity Questionnaire (IPAQ) - Short Form
Timepoint [7] 379364 0
At baseline, follow-up 1 and 2
Secondary outcome [8] 379365 0
Differences in physical function will be determined by the Short Physical Performance Battery (SPPB)
Timepoint [8] 379365 0
At baseline, follow-up 1 and 2
Secondary outcome [9] 379366 0
Assessment of an individuals "usual" dietary intake over a period of 12 months will be assessed using a food frequency questionnaire (FFQ) from the Victorian Cancer Council (DQES)
Timepoint [9] 379366 0
At baseline, follow-up 1 and 2
Secondary outcome [10] 379367 0
Differences in blood pressure (SBP/DBP), pulse and ankle brachial index (ABI) will be determined using the OMRON. This is a composite secondary outcome.
Timepoint [10] 379367 0
At baseline, follow-up 1 and 2
Secondary outcome [11] 379368 0
Indicators of kidney function from blood tests include: urea (U), electrolytes (E), creatinine (Cr), estimated glomerular filtration rate (eGFR), calcium, phosphate and magnesium.

Timepoint [11] 379368 0
At baseline and follow-up 2
Secondary outcome [12] 379755 0
Indicators of diabetes from blood tests include: glycated haemoglobin (HbA1c), fasting blood glucose
Timepoint [12] 379755 0
At baseline and follow-up 2
Secondary outcome [13] 379756 0
Indicators of cardiovascular function from blood tests include: high-density lipoproteins (HDL), low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), triglycerides, total cholesterol
Timepoint [13] 379756 0
At baseline and follow-up 2
Secondary outcome [14] 379757 0
Indicators of liver function from blood tests include: liver function tests (LFT) and c-reactive protein (CRP)
Timepoint [14] 379757 0
At baseline and follow-up 2
Secondary outcome [15] 379758 0
Vitamin D status will be determined from serum to measure 25(OH)D
Timepoint [15] 379758 0
At baseline and follow-up 2

Eligibility
Key inclusion criteria
Inclusion criteria for eligibility includes the participant:
- To identify as Aboriginal or Torres Strait Islander
- Aged 35 years and over
- Body weight less than 160 kg (maximum rating of imaging machines)
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria include:
- Pregnant women
- Lactating women
- Breastfeeding in the last 6 months

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size of 298 participants was calculated to produce a two-sided 95% confidence interval with a width of 0.04, a 20% precision (based on the DXA site with the worst precision, i.e. femoral neck), to detect a within-individual change of 2% per year (i.e. a rate that has been documented in other populations) and a 20% loss-to-follow-up. In the other DXA skeletal sites and HRpQCT regions, which can be measured with more precision, smaller rates of change will be detectable with this number of participants. The rates of bone loss will differ between men and women and may alter with age; the greatest bone loss in non-Indigenous Australians occurs in women in the first 5-10 years after menopause. Therefore, the sample size has been determined to allow investigation of bone loss in men and women separately.

The time interval of 12-15 months between scans has been selected to assess bone loss within an individual over ~3 years (baseline, follow-up 1 and follow-up 2), as the magnitude of bone loss in Aboriginal and Torres Strait Islander adults is unknown; this will ensure the age of osteoporosis (bone fragility) and sarcopenia (decreased muscle mass and function) onset is not missed.

Initially, repeated measures ANOVA will compare changes in bone and muscle parameters. Multivariable regression analyses will be performed to determine whether these associations are independent of potential confounders including age, sex, co-morbidities, physical activity and social demographics. For all analyses, a p-value of <0.05 or 95% confidence interval not including the null point will be considered statistically significant. All data will be analysed using STATA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/03/2020
Actual
17/12/2020
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
298
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15723 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 29144 0
3168 - Clayton
Recruitment postcode(s) [2] 29145 0
3175 - Dandenong
Recruitment postcode(s) [3] 29146 0
3177 - Doveton
Recruitment postcode(s) [4] 29147 0
3199 - Frankston
Recruitment postcode(s) [5] 29148 0
3000 - Melbourne
Recruitment postcode(s) [6] 29149 0
3800 - Monash University
Recruitment postcode(s) [7] 29150 0
3065 - Fitzroy
Recruitment postcode(s) [8] 29151 0
3056 - Brunswick
Recruitment postcode(s) [9] 29152 0
3066 - Collingwood

Funding & Sponsors
Funding source category [1] 304727 0
Charities/Societies/Foundations
Name [1] 304727 0
Osteoporosis Australia & Australian and New Zealand Bone and Mineral Society
Country [1] 304727 0
Australia
Funding source category [2] 304834 0
Commercial sector/Industry
Name [2] 304834 0
Amgen
Country [2] 304834 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Department of Medicine
School of Clinical Sciences at Monash Health
MHTP Translational Research Facility

Monash Medical Centre
246 Clayton Road
Clayton VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 305166 0
None
Name [1] 305166 0
Address [1] 305166 0
Country [1] 305166 0
Other collaborator category [1] 281152 0
Other
Name [1] 281152 0
Bunurong Health Service at Dandenong & District Aborigines Co-Operative Limited
Address [1] 281152 0
3 Carroll Ave, Dandenong VIC 3175
Country [1] 281152 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305152 0
Monash Health HREC
Ethics committee address [1] 305152 0
Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 305152 0
Australia
Date submitted for ethics approval [1] 305152 0
24/05/2019
Approval date [1] 305152 0
09/08/2019
Ethics approval number [1] 305152 0
RES-19-0000374A

Summary
Brief summary
There is a need to identify WHY fall and fracture risk is increased among Aboriginal and Torres Strait Islander (Indigenous) Australians.
Indigenous Australians have a substantially greater fracture risk: Indigenous men are 50% and women are 26%, more likely to experience a hip fracture vs non-Indigenous Australians. Hip fractures occur at a much younger age in Indigenous vs non-Indigenous Australians (men:65 vs 81yrs; women:74 vs 83yrs). Fall-related injuries in Indigenous Australians increased by an average of 10%/year, while the average increase in non-Indigenous Australians was 4.3%/year.
Findings from this study will identify why falls and minimal trauma fractures are higher among Indigenous adults. Data collected will enable us to determine the age of osteoporosis (bone fragility) and sarcopenia (decreased muscle function) onset, whether these are different to non-Indigenous Australians, and the best “window” for osteoporosis and sarcopenia screening and prevention strategies. Currently, there is no reference database for DXA-derived areal bone mineral density (aBMD) in Indigenous Australians, which may result in underestimation of fracture risk in this population. Data collected will be compiled into a reference database for Indigenous Australians as a starting point to collect data from Indigenous Australians in other geographic regions, with the aim of improving fracture risk prediction. Together, these data will enable health care professionals to improve screening, diagnosis and treatment of osteoporosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99414 0
Dr Ayse Zengin
Address 99414 0
Department of Medicine
School of Clinical Sciences at Monash Health
Monash University
Level 5/Block E
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 99414 0
Australia
Phone 99414 0
+61 3 8572 2918
Fax 99414 0
Email 99414 0
[email protected]
Contact person for public queries
Name 99415 0
Ayse Zengin
Address 99415 0
Department of Medicine
School of Clinical Sciences at Monash Health
Monash University
Level 5/Block E
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 99415 0
Australia
Phone 99415 0
+61 3 8572 2918
Fax 99415 0
Email 99415 0
[email protected]
Contact person for scientific queries
Name 99416 0
Ayse Zengin
Address 99416 0
Department of Medicine
School of Clinical Sciences at Monash Health
Monash University
Level 5/Block E
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 99416 0
Australia
Phone 99416 0
+61 3 8572 2918
Fax 99416 0
Email 99416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be available to share.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6687Ethical approval  [email protected] 379089-(Uploaded-31-01-2020-14-55-07)-Study-related document.pdf



Results publications and other study-related documents

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