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Trial registered on ANZCTR


Registration number
ACTRN12609000100291
Ethics application status
Approved
Date submitted
16/12/2008
Date registered
13/02/2009
Date last updated
19/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Osteo-cise: Strong Bones for Life. An Inclusive Evidence-based Multi-component Exercise, Falls Prevention and Osteoporosis Education Program.
Scientific title
Effectiveness and feasibility of a multi-site, multi-faceted exercise intervention combined with an osteoporosis education program on bone mineral density, muscle function and quality of life in community dwelling older adults at risk of osteoporosis.
Secondary ID [1] 282368 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 4100 0
Sarcopenia 4130 0
Condition category
Condition code
Musculoskeletal 4295 4295 0 0
Osteoporosis
Musculoskeletal 4327 4327 0 0
Normal musculoskeletal and cartilage development and function
Metabolic and Endocrine 4335 4335 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An 18 month randomised controlled trial (12 month intervention with 6 month follow-up) consisting of a multi-component exercise program involving resistance (strength) and power training, balance and mobility activities (60 minutes, 3 times per week for 12 months) combined with osteoporosis education sessions. These interactive education sessions (~60 minutes) will be held every 3 months (4 sessions over 12 months) at a local community/recreation centre and will include information (presentation and handout material) related to: risk factors for osteoporosis; best practice exercise and nutrition guidelines; understanding bone density results; strategies to reduce the risk of falling; communicating clearly with your doctor, and medications for the treatment of osteoporosis. All participants will receive daily calcium (700 mg) and vitamin D (1200 IU) supplements. Follow-up testing will be conducted 6 months after the intervention to assess any residual benefits.
Intervention code [1] 3810 0
Prevention
Intervention code [2] 3811 0
Lifestyle
Comparator / control treatment
Standard care self-management control group that will receive osteoporosis information (handouts) in the mail every 4 months for 12 months. Participants assigned to this group will receive general information relevant to osteoporosis (eg. Osteoporosis Australia fact sheets related to osteoporosis and risk factors, healthful nutrition recommendations, exercise for osteoporosis and falls prevention, medications and treatments for osteoporosis). The aim is to encourage participants to actively ‘take charge’ of their health in seeking out appropriate medical information and services to prevent osteoporosis, falls and fractures. All participants will receive the same daily calcium (700 mg) and vitamin D (1200 IU) supplements as the intervention group
Control group
Active

Outcomes
Primary outcome [1] 5181 0
Total body, hip and lumbar spine bone mineral density measured by Dual Energy X-ray Absorptiometry (DXA) and bone structure (distal femur and proximal tibia) measured by magnetic resonance imaging (MRI).
Timepoint [1] 5181 0
Measurements will be made at baseline, 12 and 18 months (except for MRI which will be assessed at baseline and 18 months only).
Primary outcome [2] 5182 0
Muscle strength and power of the back and lower limbs measued by one repetition maximum (1-RM) testing; body composition (lean mass and fat mass) measured by DXA and MRI.
Timepoint [2] 5182 0
Strength measurements will made at baseline and every 6 months during the 12 month intervention, and then at the 6 month follow-up testing. Body composition will be measured as per the body density testing
Primary outcome [3] 5183 0
Dynamic balance, power and gait speed will be measured using the timed-up-and-go, functional reach, four square and stair-climbing tests.
Timepoint [3] 5183 0
Measurements will be made at baseline and every 6 months during the 12 month intervention, and then at the 6 month follow-up testing.
Secondary outcome [1] 8725 0
Serum vitamin D, parathyroid hormone and bone turnover markers.
Timepoint [1] 8725 0
Measurements will be made at baseline, 6, 12 and 18 months.
Secondary outcome [2] 8726 0
Risk factors for cardiovascular disease (pro- and anti- inflammatory markers and profile of lipids).
Timepoint [2] 8726 0
Measurements will be made at baseline, 6, 12 and 18 months.
Secondary outcome [3] 8727 0
Knee volume and structure (cartilage defects, bone size and bone marrow lesions) will be assessed by MRI.
Timepoint [3] 8727 0
Measurements will be made at baseline and 18 months.
Secondary outcome [4] 8728 0
Falls incidence monitored by a falls calendar
Timepoint [4] 8728 0
Everyday during the 12 month intervention and 6 month follow-up.
Secondary outcome [5] 8729 0
Osteoporosis knowledge, beliefs, attitudes and prevention behaviours assessed by the Osteoporosis Knowledge and the Osteoporosis Health Belief Scale questionnaires.
Timepoint [5] 8729 0
Measurements will be made at baseline, 6, 12 and 18 months.
Secondary outcome [6] 8730 0
Health-related quality of life assessed by the SF-36 questionnaire
Timepoint [6] 8730 0
Measurements will be made at baseline, 6, 12 and 18 months.

Eligibility
Key inclusion criteria
Osteopenia in the hip (Femoral neck or total hip BMD T-score: -1.0 to -2.5 SD)
Minimum age
60 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or prior (6 months) participation in resistance training or a structured weight-bearing exercise program, acute or terminal illness, moderate or severe cognitive impairment (inability to understand and provide written informed consent and/or follow instructions), unstable or ongoing cardiovascular/respiratory disorders, musculoskeletal or neurological disease disrupting voluntary movement or that might limit training, upper or lower extremity fracture in the past 3 months, unwillingness to be randomised to one of the two groups or complete the study requirements.

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)
Participant ID numbers will be randomly allocated by personnel not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will be computer generated (using a random number generator) in blocks after stratification by gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4262 0
Charities/Societies/Foundations
Name [1] 4262 0
JO & JR Wicking Trust/Osteoporosis Australia
Address [1] 4262 0
GPO Box 121
Sydney 2001
New South Wales
Country [1] 4262 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Department of Medicine
Western Hospital
Footscray
Victoria 3011
Country
Australia
Secondary sponsor category [1] 285907 0
University
Name [1] 285907 0
Deakin University
Address [1] 285907 0
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne, Victoria 3129
Country [1] 285907 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6340 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 6340 0
Office for Research
6 East, Main Block
The Royal Melbourne Hospital
PARKVILLE VIC 3050
Ethics committee country [1] 6340 0
Australia
Date submitted for ethics approval [1] 6340 0
Approval date [1] 6340 0
17/09/2008
Ethics approval number [1] 6340 0
2008-136

Summary
Brief summary
Osteoporosis and low trauma fractures currently affect 2.2 million Australians, which is projected to rise to three million people by 2021, with a fracture occurring every 3½ minutes. Currently the medical paradigm of ‘cure’ for osteoporosis is less than ideal because the limited pharmacological agents available are directed to those who already have the disease or are at increased risk. A more effective approach to reduce the burden of this disease is prevention at the population level. That is, defining models that are efficacious, safe, and can be implemented to a large cross-section of the community. Exercise fulfils most of these criteria, with the added advantage of having beneficial effects on multiple health outcomes. The aim of this 18 month RCT is to evaluate the feasibility and effectiveness of a community-based exercise (high velocity resistance and weight-bearing exercise) and osteoporosis education/awareness program for optimising musculoskeletal health and function and general well-being in older Australians at increased risk of osteoporosis and fractures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35021 0
Prof Robin Daly
Address 35021 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne Victoria 3125
Country 35021 0
Australia
Phone 35021 0
+6139244 6040
Fax 35021 0
Email 35021 0
rmdaly@deakin.edu.au
Contact person for public queries
Name 12368 0
Dr Dr Christine Bailey
Address 12368 0
The University of Melbourne
Department of Medicine
Western Hospital
Footscray
Victoria 3011
Country 12368 0
Australia
Phone 12368 0
+6138345 7164
Fax 12368 0
Email 12368 0
cbailey@unimelb.edu.au
Contact person for scientific queries
Name 3296 0
Prof Robin Daly
Address 3296 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne Victoria 3125
Country 3296 0
Australia
Phone 3296 0
+61392446040
Fax 3296 0
Email 3296 0
rmdaly@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary