Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000898257
Ethics application status
Approved
Date submitted
6/07/2009
Date registered
15/10/2009
Date last updated
15/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot study of Whole Body Vibration in Children with Osteogenesis Imperfecta
Scientific title
A randomised, blinded pilot study of one year duration to detertmine the safety and efficacy of using a vibration plate for part of the multidisciplinary treatment of children with Osteogenesis Imperfecta
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteogenesis Imperfecta Type l - Vlll 4891 0
brittle bones 237158 0
decreased muscle tone 237159 0
decreased mobility 237170 0
Condition category
Condition code
Musculoskeletal 237248 237248 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both child and parent/carer who are randomised into the vibration arm of the study, will be instructed by the treating physiotherapist to use the Juvent vibration plate. They will be asked to undertake a 12 months program, to stand on the plate for 20 minutes daily.
Frequency is at a low-level (30Hz) as these forces are less than the skeleton experiences through normal ambulation,as such unlikely to result in adverse skeletal events.
Intervention code [1] 236681 0
Treatment: Devices
Comparator / control treatment
Standard treatment group:- children randomised into the control arm of the study will continue their normal level of activity with standard care, investigations as per treatment for Osteogenesis Imperfecta(brittle bones)
Control group
Active

Outcomes
Primary outcome [1] 238061 0
Muscle and Functional Measurements:-
*Peak Jump Force (PJF), Peak Jump Power (PJP) & Jump velocity, performed on the Leonardo Jumping Platform, includes a computer program for analysis.
*Maximum Force in relation to body weight, where the children are asked to do multiple one-legged jumps on the Leonardo Jumping Platform.
*Chair Raising Test, (5 time in ane cycle) sit to stand on the Leonardo Jumping Platform.
*Grip Force, using a standard hand dynamometer.
*Functional Assessment for gross-motor and self-care abilities.
* Mobility using the Bleck Score e.g 0 (does not walk - 3 (able to walk in the community).
Timepoint [1] 238061 0
Baseline, 6 and 12 months
Functional Assessment is also done at baseline, 3, 6 & 12 months.
Primary outcome [2] 238062 0
Densitometric Measurements:-
1. Peripheral Quantitive Computer Tomography (pQCT) using 3 sites of the non-dominant Tibia, analysis of total and trabecular volumetric bone mineral density.
2. Dual energy X-ray absorptiometry (DXA)using total body and lumbar spine, analysis of bone mineral content, projected bone area and lean tissue mass.
Timepoint [2] 238062 0
Baseline, 6 and 12 months
Primary outcome [3] 238063 0
Radiological Measurements:-
*Antero-posterior and lateral thoraco-lumbar spine. Cobb angle (AP) and vertebral morphometry will be assessed.
Additional x-rays only as clinically indicated e.g follow-up fractures, performed 6th monthly.
Timepoint [3] 238063 0
Baseline, (6) and 12 months
Secondary outcome [1] 242249 0
Clinical Chemistry Measurements:- the following biochemical measures are to be performed:-
Whole Blood (Full blood count), Serum and Urine. Analysis of biochemical homeostasis
Timepoint [1] 242249 0
Baseline, 6 and 12 months
Secondary outcome [2] 242250 0
Exploratory and Safety measurments
*Patient Questionaire, to evaluate the acceptibility of the whole body vibration trial.
*Physical examination, at each visit a physical will be performed, this includes weight and height measurements. growth rates will be calculated from the height measurements.
*Fracture Rates, diagnosed according to radiological evidence. Parents are asked to report by telephone within 24 hours.
*Skeletal Pain, a dairy is to be kept to record episodes of pain. The Wong-Baker FACES Pain Rating scale will be used at each visit.
*Quality of Life, using the PedsQL questionaires, according to specific age groups.
Timepoint [2] 242250 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
Diagnosis of Osteogeneis Imperfecta (Type l -Vll)
To be able to stand on the vibration paltform for a 20 minute period
Able and willing to particpate with parent/legal guardian written consent.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current pregnancy
Lower limb fracture within 8 weeks of enrollment
Untreated Rickets within 6 months of enrollment
Serum 25(OH)2 Vitamin D <39nmol/l
History of clinically significant organic or psychiatric disease.
History of using medications such as, anabolic agents, calcitriol, calcitonin, fluoride, oestrogen, progestogens, growth hormone, Parathyroid hormone (PTH)
Osteoporosis secondary to diseases other than Osteogenesis Imperfecta (OI)
Osteoporosis secondary to drug therapies.
Current use of anticonvulsant medication
Current use of anticoagulant medication

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)
A children with Osteogenesis Imperfecta from the hospital database and where subjects were paired by age and disease severity.
Allocation concealment by central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures such as coin tossing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237109 0
Commercial sector/Industry
Name [1] 237109 0
Surgical Synergies Pty Ltd
Country [1] 237109 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Surgical Synergies Pty Ltd
Address
PO Box 28
Regents Park NSW 2143
Sydney
Country
Australia
Secondary sponsor category [1] 4609 0
Hospital
Name [1] 4609 0
The Children's Hospital at Westmead
Address [1] 4609 0
Locked Bag 4001
Westmead NSW 2145
Sydney
Country [1] 4609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239207 0
The Royal Alexandria Hospital for Children Ethics Committee
Ethics committee address [1] 239207 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2146
Sydney
Ethics committee country [1] 239207 0
Australia
Date submitted for ethics approval [1] 239207 0
Approval date [1] 239207 0
Ethics approval number [1] 239207 0
Project Number: 07/CHW/10

Summary
Brief summary
Aims of this project:
*To investigate if whole body vibration training is effective and well tolerated over the short-to medium-term.
*Medium-term home based training program will evaluate if whole body vibration training influences:- mobility, muscle power and force, muscle mass & bone mass.
The hypothesis:-
*Is that over a six month period the aims of effectivness and tolerance can be noted in children with Osteogenesis Imperfecta.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29677 0
Address 29677 0
Country 29677 0
Phone 29677 0
Fax 29677 0
Email 29677 0
Contact person for public queries
Name 12924 0
Dr. Craig Munns
Address 12924 0
Staff Specialist, Bone and Mineral Medicine, Endocrinology
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 12924 0
Australia
Phone 12924 0
+61 2 9845 3136
Fax 12924 0
+61 2 9845 3170
Email 12924 0
[email protected]
Contact person for scientific queries
Name 3852 0
Dr. Craig Munns
Address 3852 0
Staff Specialist, Bone and Mineral Medicine, Endocrinology
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 3852 0
Australia
Phone 3852 0
+61 2 9845 3136
Fax 3852 0
+61 2 98453170
Email 3852 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

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