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Trial registered on ANZCTR


Registration number
ACTRN12615000848505
Ethics application status
Approved
Date submitted
4/08/2015
Date registered
14/08/2015
Date last updated
14/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole body vibration for osteoporosis: Shaking up treatment options.
Scientific title
A double-blinded, block-randomised, placebo-controlled clinical trial investigating the effects of low intensity whole body vibration (LWBV) on risk factors for hip fracture in post-menopausal women.
Secondary ID [1] 287122 0
Nil known
Universal Trial Number (UTN)
U1111-1172-3652
Trial acronym
VIB OP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 295656 0
Hip fractures 295657 0
Osteopenia 295820 0
Vertebral fracture 295821 0
Condition category
Condition code
Musculoskeletal 295935 295935 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Participants taking osteoporosis (OP) medication will stand on low intensity whole body vibration (LWBV) device (30Hz) for 10 min/day, 5 day/week (for first 12 months) and receive no vibration treatment for the second 12 months. Adherence to the intervention will be monitored through a diary provided to the participants to record their treatment.

Arm 2: Participants not taking OP medication will stand on LWBV device for 10 min/day, 5 day/week (for first 12 months) and receive no vibration treatment for the second 12 months. Adherence to the intervention will be monitored through a diary provided to the participants to record their treatment.
Intervention code [1] 292426 0
Treatment: Devices
Intervention code [2] 292551 0
Treatment: Other
Comparator / control treatment
Note: Active devices will provide a 30 Hz, 0.4 g vertical mechanical perturbation. The active and sham devices are almost indistinguishable when operating as the LWBV stimulus is virtually imperceptible and both devices emit the same audible hum.

Arm 3: Participants taking OP medication will stand on sham LWBV device for 10 min/day, 5 day/week (for first 12 months) and receive no vibration treatment for the second 12 months. Adherence to the intervention will be monitored through a diary provided to the participants to record their treatment.

Arm 4: Participants not taking OP medication will stand on sham LWBV device for 10 min/day, 5 day/week (for first 12 months) and receive no vibration treatment for the second 12 months. Adherence to the intervention will be monitored through a diary provided to the participants to record their treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 295666 0
Bone mineral density of bilateral femoral neck measured by Dual energy X-ray absortiometry (DXA) in treatment and control groups.
Timepoint [1] 295666 0
1) Pre-intervention (Baseline) 2) Post-intervention (12th month) 3) Post-Detraining (24th month)
Primary outcome [2] 295667 0
Bone mineral density of bilateral femoral neck measured by Dual energy X-ray absortiometry (DXA) in treatment versus control groups and participants with and without OP medications.
Timepoint [2] 295667 0
1) Pre-intervention (Baseline) 2) Post-intervention (12th month) 3) Post-Detraining (24th month)
Secondary outcome [1] 316159 0
Muscle function: pQCT-derived calf muscle mass and density in treatment vs control groups.
Timepoint [1] 316159 0
1) Pre-intervention (Baseline) 2) Post-intervention (12th month) 3) Post-Detraining (24th month)
Secondary outcome [2] 316160 0
Muscle function: pQCT-derived calf muscle mass and density in treatment vs control groups,and participants with and without OP medications.
Timepoint [2] 316160 0
1) Pre-intervention (Baseline) 2) Post-intervention (12th month) 3) Post-Detraining (24th month)
Secondary outcome [3] 316161 0
Total number of falls (fractures) recorded in a daily diary over the 24 months of participation.
Timepoint [3] 316161 0
Daily diary.
Secondary outcome [4] 316162 0
Quality of Life, AQoL-6D to calculate QALYs
Timepoint [4] 316162 0
1) Pre-intervention (Baseline) 2) Post-intervention (12th month) 3) Post-Detraining (24th month) for AQoL and daily for 24 months for health costs evaluation.
Secondary outcome [5] 316412 0
Health costs based on general practitioner (GP), emergency department (ED) visits, hospital admissions, procedures and diagnosis.

Health service use data will be obtained from Qld Health (for inpatient and outpatient procedures, costed using Diagnostic Related Groups - AR-DRGs v5.2). GP visits and community care will be obtained from study diaries. Incremental cost-effectiveness ratio's (ICERs) will be calculated by comparing intervention and control groups.
Timepoint [5] 316412 0
1) Post-invention (12th month) 2) Post-Detraining (24th month)

Eligibility
Key inclusion criteria
1) women
2) at least 5 year post-menopause
3) with low bone mineral density (hip BMD t score lesser than or equal to -1.0)
4) with or without anti-absorptive osteoporosis drug with no plans to change therapy for the next 24 months
Minimum age
60 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Fraility
2) Cannot stand unaided
3) Cognitive impairment
4) high level of physical activity
5) malignancy
6) On the following medications, Strontium ranelate or anabolic osteoporosis medication e.g. parathyroid hormone, corticosteroids, thyroxine, thiazide or anti-viral agents
7) have conditions known to influence bone health e.g. thyrotoxicosis or hyperthyroidism, Paget's disease, renal diseases and diabetes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block randomisation will be used to ensure equal number of participants are assigned to intervention and control groups, with and without OP medications. The manufacturer will label active and sham devices with consecutive serial numbers in each of two computer-generated permuted block random sequences. The allocation codes for each block will be generated and provided to the manufacturer by the data manager who will be independent of the study site and activities.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Intention-to-treat analyses

At 12 months, separate analyses of the two primary hypotheses (with and without OP meds) will be performed. Femoral neck BMD loss is defined as [12 month femoral neck BMD] minus [0 month femoral neck BMD] = 0. To compare proportions of participants gaining or maintaining femoral neck BMD by treatment groups in both primary and secondary hypotheses, logistic regression models will be used, with adjustments for age, baseline values, BMI, physical activity, calcium consumption and serum 25(OH)D. The coefficient of variation of repeat measures of femoral neck BMD in our lab is 1.5% with a small root mean square error of 0.002 g/cm2. BMD measurement error will be appropriately addressed by adjusting the estimated odds ratios obtained from logistic regression models following standard statistical techniques71. Repeated measures comparisons of mean change in femoral neck BMD (gm/cm2) and secondary outcomes will also be conducted using univariate analyses, controlling for initial values, calcium, vitamin D and compliance. Separate analyses on adherence to medication will be conducted using treatment log diaries and information obtained during study visits and monthly meetings. The change in QoL scores over time will be compared between study groups using appropriate parametric and non-parametric techniques. Further exploratory analyses will include examination of secondary hypotheses and possible associations of anthropometric and compliance factors on the study outcomes. At 24 months, repeat analyses will be conducted to examine whether any treatment effect has been maintained.

In the absence of published data indicating the minimum percent improvement in the proportion of women losing bone over the course of a year required for public health benefit, we based our power calculations on a conservative estimate of 20%. Thus, from a two-sample difference of proportions test for 80% power with type 1 error of 5%, a sample size of 186 is required to detect hip BMD maintenance or gain in 50% of the LWBV group (30%+20%). As a 2-year, home-based study could potentially experience greater attrition, we will over-recruit by 15% to power our exploratory analyses. Thus, to test primary hypothesis 1, we will recruit 214 participants (186 + 28).

Similarly, no published data are available on which to base an estimate of the proportion of women on established OP meds who will gain BMD at the femoral neck over the course of a year. The single available study reporting related data cites a figure of roughly 88%49. Those data, however, represent the response to novel anti-resorptive therapy and are derived from a per protocol analysis. It is reasonable to assume the proportion of OP med participants observed gaining femoral neck BMD in the current study will be considerably less than 88%, given our intention-to-treat analysis, and their established drug treatment regime. Therefore, under the same assumption that a minimum 20% improvement in the proportion of participants gaining hip BMD is necessary for public health benefit to be achieved, and estimating 50% of participants on medications will gain hip BMD, to observe hip BMD gain in 70% (50%+20%) of the LWBV + OP meds group (with 80% power and 5% type 1 error), a sample size of 186 is again required. Including 15% over-recruitment to power exploratory analyses increases the number required to test primary hypothesis 2 to 214. Thus, to independently test both primary hypotheses, a total study n of 214 + 214 = 428 participants is required.

Recruitment
Recruitment status
Not yet recruiting
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)
QLD

Funding & Sponsors
Funding source category [1] 291738 0
Government body
Name [1] 291738 0
National Health and Medical Research Council (NHMRC)
Project Grant Scheme 2015 - 2018
Address [1] 291738 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 291738 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 290412 0
None
Name [1] 290412 0
Address [1] 290412 0
Country [1] 290412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293260 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 293260 0
170 Kessels Road
Nathan
QLD 4111
Ethics committee country [1] 293260 0
Australia
Date submitted for ethics approval [1] 293260 0
18/11/2014
Approval date [1] 293260 0
16/12/2014
Ethics approval number [1] 293260 0
AHS/61/14/HREC

Summary
Brief summary
For the many individuals with established osteoporosis who will not, or cannot take medication there are currently no recommended therapeutic alternatives. Exercise, calcium and vitamin D are vital but insufficient therapies and are similarly limited by poor patient compliance. Whole body vibration (WBV) can be anabolic to the musculoskeletal system. Early research has shown that WBV is a simple, passive therapy with much greater appeal to the target population than exercise or drugs. This trial will be the first to use rigorous methods to examine the effects of WBV alone, and in combination with drug therapy, to improve risk factors for hip fracture (bone density, balance and muscle strength).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58906 0
A/Prof Belinda Beck
Address 58906 0
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport
QLD 4222
Country 58906 0
Australia
Phone 58906 0
+61 7 55528793
Fax 58906 0
+61 7 55528674
Email 58906 0
b.beck@griffith.edu.au
Contact person for public queries
Name 58907 0
A/Prof Belinda Beck
Address 58907 0
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport
QLD 4222
Country 58907 0
Australia
Phone 58907 0
+61 7 55528793
Fax 58907 0
+61 7 55528674
Email 58907 0
vib-op@griffith.edu.au
Contact person for scientific queries
Name 58908 0
A/Prof Belinda Beck
Address 58908 0
School of Allied Health Sciences
Gold Coast campus
Griffith University
Parklands Drive
Southport
QLD 4222
Country 58908 0
Australia
Phone 58908 0
+61 7 55528793
Fax 58908 0
+61 7 55528674
Email 58908 0
b.beck@griffith.edu.au

No data has been provided for results reporting
Summary results
Not applicable