Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000491460
Ethics application status
Approved
Date submitted
4/09/2007
Date registered
24/09/2007
Date last updated
16/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Research study into the effect of vibration platform training on bone health in postmenopausal women
Scientific title
Research study into the efficacy of a new device for musculoskeletal health in osteopenic and osteoporotic populations at risk of fracture: a sequence of pilot projects leading to a major intervention
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporotic Fracture 2332 0
Condition category
Condition code
Musculoskeletal 2434 2434 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vibration platform (12Hz, 0.3G, 20 minutes intermittent vibration [1 minute on, 30 seconds off], 8 weeks, 1-3 times per week)
Intervention code [1] 2049 0
Treatment: Devices
Comparator / control treatment
Placebo group (Placebo vibration platform, 20 minutes continuous, 1 times per week, 8 weeks)
Control group
Placebo

Outcomes
Primary outcome [1] 3332 0
Blood Borne markers of Bone formation- OSTASE (bone specific alkaline phosphatase).
Timepoint [1] 3332 0
Baseline, 8 weeks
Primary outcome [2] 3333 0
Blood Borne markers of Bone resorption- NTx (N-telopeptide X)
Timepoint [2] 3333 0
Baseline, 8 weeks
Secondary outcome [1] 5545 0
Muscle strength- Bilateral Leg press 1 Repetition Maximum (1RM)/ Bilateral Chest Press 1RM
Timepoint [1] 5545 0
Baseline, 8 weeks
Secondary outcome [2] 5546 0
Performance Based Testing (Stair Climb, Balance, Chair Stand, Habitual Gait Velocity and Maximum Gait Velocity)
Timepoint [2] 5546 0
Baseline, 8 weeks
Secondary outcome [3] 5622 0
Peripheral quantitative computed tomography (pQCT)
Timepoint [3] 5622 0
Baseline

Eligibility
Key inclusion criteria
Currently postmenopausal for at least 1yr;
Free from diseases related to bone metabolism other that osteoporosis (e.g. hyperthyroidism); Willing to continue taking any supplements and/or bone altering medications currently being taken ; able to stand unassisted on the platform for a sustained period (e.g. up to 20 minutes); free from cognitive impairment; without terminal disease
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Thyroid disease, Paget's disease, Chronic kidney disease, rheumatoid arthritis, multiple myeloma, vitamin D deficiency, hyperparathyroidism, inability to stand unassisted for sustained periods of time

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)
Both tested and subject were blinded to allocation. Allocation concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation (years since menopause, medications, exerciser status) using a randomization table created by a computer software
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
18/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 251 0
2096
Recruitment postcode(s) [2] 252 0
2092
Recruitment postcode(s) [3] 253 0
2100
Recruitment postcode(s) [4] 254 0
2099
Recruitment postcode(s) [5] 255 0
2095
Recruitment postcode(s) [6] 256 0
2093
Recruitment postcode(s) [7] 440 0
2099

Funding & Sponsors
Funding source category [1] 2587 0
University
Name [1] 2587 0
University of Sydney
Country [1] 2587 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Cumberland Campus
Faculty of Health Sciences
75 East St
Lidcombe
NSW
Country
Australia
Secondary sponsor category [1] 2339 0
Other
Name [1] 2339 0
Dr Geraldine Naughton
Address [1] 2339 0
Australian Catholic University
Country [1] 2339 0
Australia
Other collaborator category [1] 48 0
University
Name [1] 48 0
Australia Catholic University
Address [1] 48 0
Strathfield
NSW
Country [1] 48 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4509 0
Human Research Ethics Committee (University of Sydney)
Ethics committee address [1] 4509 0
Ethics committee country [1] 4509 0
Australia
Date submitted for ethics approval [1] 4509 0
Approval date [1] 4509 0
Ethics approval number [1] 4509 0
02-2004/7132
Ethics committee name [2] 4558 0
Human Research Ethics Committee (HREC)
Ethics committee address [2] 4558 0
Ethics committee country [2] 4558 0
Australia
Date submitted for ethics approval [2] 4558 0
Approval date [2] 4558 0
Ethics approval number [2] 4558 0

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

Contacts
Principal investigator
Name 28029 0
Address 28029 0
Country 28029 0
Phone 28029 0
Fax 28029 0
Email 28029 0
Contact person for public queries
Name 11186 0
Sarah Walker
Address 11186 0
University of Sydney
CUmberland Campus
Faculty of Health Sciences
PO BOX 170
Lidcombe
Country 11186 0
Australia
Phone 11186 0
0424600307
Fax 11186 0
Email 11186 0
swal9910@mail.usyd.edu.au
Contact person for scientific queries
Name 2114 0
Prof. Maria Fiatarone Singh
Address 2114 0
University of Sydney
CUmberland Campus
Faculty of Health Sciences
PO BOX 170
Lidcombe
Country 2114 0
Australia
Phone 2114 0
0293519755
Fax 2114 0
0293519204
Email 2114 0
m.singh@usyd.edu.au

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.