Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000782730p
Ethics application status
Not yet submitted
Date submitted
20/05/2022
Date registered
1/06/2022
Date last updated
1/06/2022
Date data sharing statement initially provided
1/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Cerebral Palsy Musculoskeletal Health Network: Bone Quality in Children with Cerebral Palsy
Scientific title
Australian Cerebral Palsy Musculoskeletal Health Network: Bone Biopsy to Examine Bone Quality in children with Cerebral Palsy
Secondary ID [1] 307183 0
2015970
Universal Trial Number (UTN)
U1111-1278-5537
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 326405 0
Scoliosis 326406 0
Hip Displacement 326407 0
Skeletal fragility 326408 0
Condition category
Condition code
Neurological 323692 323692 0 0
Other neurological disorders
Musculoskeletal 323693 323693 0 0
Osteoporosis
Musculoskeletal 323694 323694 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transiliac bone biopsy
Lay description:
What is a Transiliac Bone Biopsy?

A transiliac bone biopsy is when a small piece of bone is taken from the hip so that it can be looked at under a microscope.

Why does the doctor want to do a Transiliac Bone Biopsy?

If it has been suggested that a transiliac bone biopsy be done then your child has a significant bone problem. Where possible, the cause of the bone problem and the best way of treating it will be worked out by using other investigations such as x-ray and blood tests. If, when all usual tests are done it is still unclear what is wrong with your child’s bones, or to make sure that treatment is going to plan, a transiliac bone biopsy may be needed. In these situations the best way to find out what is wrong with the bone is to get a bit of it and look at it under a microscope.

What does having a Transiliac Bone Biopsy involve?

A transiliac bone biopsy involves having minor surgery where a small piece of bone is taken from the hip. This is done at The Children’s Hospital at Westmead under a general anaesthetic.

Before the biopsy:
On days 17, 16, 5 and 4 before the biopsy it is very important that the antibiotic Demeclocycline is taken twice a day as outlined on the Labelling Sheet. This medication is taken to give information on the way bone is made. If the medication is not taken as recommended, the biopsy is less useful.

Day of the biopsy:
On the day of the transiliac bone biopsy your child will come to Middleton Ward of the Children’s Hospital at Westmead by 8am. Your child should be fasting i.e. nothing to eat or drink from 12 midnight the night before. Your child will be seen by an anaesthetist who will make sure that he/she is well. If your child is unwell on the day before or the morning of the biopsy, please phone Dr Craig Munns (02) 9845-3200.

When it is time for the biopsy to occur, your child will be taken into the operating room. They will be put to sleep either by breathing gas or having an IV cannula put into a vein and medication given. Once asleep, a small cut (2 cm) will be made in the skin at the top of the hip and a small piece of bone (5 – 7 mm or the size of the top of a pen) will be taken. The skin will be stitched using 2 – 3 dissolvable stitches. A large bandaid will be placed over the stitches.





After the biopsy:
Your child will have to lay flat for 3 hours after the biopsy to make it less likely that bleeding will occur. After 3 hours your child will be able to go home as long as they are able to eat. The area where the biopsy was taken from should be kept dry for 48 hours. Panadol is usually all that is needed to control pain. If any stitches have not dissolved and come out after 10 days they will need to be removed by your local doctor.

What are the possible complications of a Transiliac Bone Biopsy?

A transiliac bone biopsy is a relatively safe procedure. The three possible side effects are:
1. Bleeding – the chances of this occurring are decreased by the doctor putting pressure on the biopsy area at the time the biopsy is taken, and by your child laying flat for 3 hours after the biopsy is done.
2. Infection – the chance of the wound getting infected is decreased by the doctor using a ‘sterile technique’ to take the biopsy, and by keeping the area dry for 48 hours after the biopsy.
3. Pain at the site of the biopsy – this is usually mild and decreased by using Panadol. Almost all children are able to do their normal activities the day after the biopsy is taken.

There is a small risk associated with any anaesthetic. The risk is less if the anaesthetic is given when your child is well. This means we will not do the biopsy if your child is sick and will rebook it for a time when he / she is well.

When will we know the result of the Transiliac Bone Biopsy?

Because of the complexity of analysing the biopsy and because it has to be sent to Canada for analysis, it can take 4 – 6 months to get the full result. In certain situations a result can be available earlier.

Biopsy will be performed by Prof Munns

Biopsy will be undertaken at Queensland Children's Hospital (Prof Munns). Analysis will occur at Queensland Institute of Technology (Prof Peter Pivonka)

Each while (n=30) will have only one biopsy performed undertaken at the same time the child is having their scheduled hip surgery. The biopsy is done under a general anaesthetic.

The information is for research purposes only. It will not influence treatment.

The work at QUT will be done under strict quality control conditions.

Dosage of Demeclocycline: 15-20 mg/kg/day (Maximum: 900 mg/day). Demeclocycline is available in 150 mg capsules to be taken orally. Demeclocycline taken in two divided doses 17, 16, 5 and 4 days before planned date of biopsy.
Intervention code [1] 323637 0
Early detection / Screening
Comparator / control treatment
Published normative reference data by comparing the results of the study with the aggregated results in publication below.
Fratzl-Zelman N. Normative data on mineralization density distribution in iliac bone biopsies of children, Kadolescents and young adults. Bone. 2009;Jun;44(6):1043-8
Control group
Historical

Outcomes
Primary outcome [1] 331443 0
Histomorphometry: Bone volume / Tissue Volume

Standard histormorphomety is performed on transiliac bone biopsy sample as described by Glorieux et al. After sample preparation, bone samples are evaluated under light microscopy.
Normative data for iliac bone histomorphometry in growing children.
Glorieux FH, Travers R, Taylor A, Bowen JR, Rauch F, Norman M, Parfitt AM.
Bone. 2000 Feb;26(2):103-9. doi: 10.1016/s8756-3282(99)00257-4.
Timepoint [1] 331443 0
Once during 5 years of study
Primary outcome [2] 331444 0
Histomorphometry: Bone formation rate

Standard histormorphomety is performed on transiliac bone biopsy sample as described by Glorieux et al. After sample preparation, bone samples are evaluated under light microscopy.
Normative data for iliac bone histomorphometry in growing children.
Glorieux FH, Travers R, Taylor A, Bowen JR, Rauch F, Norman M, Parfitt AM.
Bone. 2000 Feb;26(2):103-9. doi: 10.1016/s8756-3282(99)00257-4.
Timepoint [2] 331444 0
Once during 5 years of study
Primary outcome [3] 331445 0
Histomorphometry: Cortical width
Standard histormorphomety is performed on transiliac bone biopsy sample as described by Glorieux et al. After sample preparation, bone samples are evaluated under light microscopy.
Normative data for iliac bone histomorphometry in growing children.
Glorieux FH, Travers R, Taylor A, Bowen JR, Rauch F, Norman M, Parfitt AM.
Bone. 2000 Feb;26(2):103-9. doi: 10.1016/s8756-3282(99)00257-4.
Timepoint [3] 331445 0
Once during 5 years of study
Secondary outcome [1] 409903 0
Primary Outcome:
Bone mineral density distribution (BMDD). The gold standard for assessment of BMDD is quantitative backscattering electron microscopy imaging (qBEI).
Normative data of BMDD is established in Typically Developing Children.
Timepoint [1] 409903 0
Once during 5 years of study

Eligibility
Key inclusion criteria
Children 4 - 18 years of age with cerebral palsy undergoing hip surgery where the ilium is exposed.
Minimum age
4 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwillingness to provide assent or consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics to describe the bone phenotype and compare to normative data using one-way t-test. A Mann-Whitney U-test will be performed if sample not normally distributed

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22415 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 37580 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 311489 0
Government body
Name [1] 311489 0
Australian Government Department of Health (Medical Research Future Fund)
Country [1] 311489 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 312890 0
None
Name [1] 312890 0
Address [1] 312890 0
Country [1] 312890 0
Other collaborator category [1] 282317 0
University
Name [1] 282317 0
Queensland University of Technology
Address [1] 282317 0
2 George Street, Brisbane Queensland 4000
Country [1] 282317 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310950 0
University of Queensland
Ethics committee address [1] 310950 0
Ethics committee country [1] 310950 0
Australia
Date submitted for ethics approval [1] 310950 0
06/06/2022
Approval date [1] 310950 0
Ethics approval number [1] 310950 0

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

Contacts
Principal investigator
Name 119466 0
Prof Craig Munns
Address 119466 0
Centre for Children’s Health Research (CCHR)
Room 603, UQ Child Health Research Centre
62 Graham Street
South Brisbane Qld 4101
Country 119466 0
Australia
Phone 119466 0
+61 148692075
Fax 119466 0
Email 119466 0
[email protected]
Contact person for public queries
Name 119467 0
Craig Munns
Address 119467 0
Centre for Children’s Health Research (CCHR)
Room 603, UQ Child Health Research Centre
62 Graham Street
South Brisbane Qld 4101
Country 119467 0
Australia
Phone 119467 0
+61 7 3069 7362
Fax 119467 0
Email 119467 0
[email protected]
Contact person for scientific queries
Name 119468 0
Craig Munns
Address 119468 0
Centre for Children’s Health Research (CCHR)
Room 603, UQ Child Health Research Centre
62 Graham Street
South Brisbane Qld 4101
Country 119468 0
Australia
Phone 119468 0
+61 7 3069 7362
Fax 119468 0
Email 119468 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16155Study protocol  [email protected] Contact PI
16156Ethical approval  [email protected]



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.