Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001048572
Ethics application status
Approved
Date submitted
2/09/2015
Date registered
7/10/2015
Date last updated
7/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Zoledronic acid to improve low bone mineral density in non-ambulatory adults with cerebral palsy
Scientific title
Zoledronic acid to improve low bone mineral density in non-ambulatory adults with cerebral palsy
Secondary ID [1] 287393 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 296099 0
osteoporosis 296100 0
Condition category
Condition code
Musculoskeletal 296354 296354 0 0
Osteoporosis
Neurological 296355 296355 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4mg zoledronic acid (intravenous) to be given as a once off infusion
Calcium supplementation: 1000mg daily orally/via PEG
Vitamin D supplementation: 2000 international units daily orally/via PEG
Calcium and vitamin D supplementation will commence prior to infusion to ensure adequate levels and reduction of side effects
Laboratory testing will be performed to determine if vitamin D supplementation is adequate
Intervention code [1] 292746 0
Treatment: Drugs
Comparator / control treatment
No placebo infusion will be given
Calcium supplementation: 1000mg daily
Vitamin D supplementation: 2000 international units daily
Laboratory testing will be performed to determine if vitamin D supplementation is adequate
Control group
Active

Outcomes
Primary outcome [1] 296004 0
changes in bone mineral density as measured by dual energy xray absorptiometry (DXA)
Timepoint [1] 296004 0
12 and 24 months
Secondary outcome [1] 317210 0
changes in bone density as measured by high resolution peripheral quantitative computed tomography (HR-pQCT)
Timepoint [1] 317210 0
12 and 24 months
Secondary outcome [2] 317211 0
Changes in bone turnover markers (serum ALP, CTX, P1NP -all assessed through blood samples)
Timepoint [2] 317211 0
12 and 24 months

Eligibility
Key inclusion criteria
aged greater or equal to 18 years
cerebral palsy
non ambulatory (includes those who can stand for transfers only).
Z score at lumbar spine or proximal femur less or equal to -2.0
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Secondary cause for bone disease (hypoparathyroidism, hyperparathyroidism, hypothyroidism, hyperthyroidism, rheumatoid arthritis, Paget’s disease
- Hypocalcaemia/hypercalcaemia
- Previous use of bisphosphonates in the last 2 years
- Current use of medication to treat osteoporosis: strontium, denosumab
- Use of glucocorticoids (washout period of 1 year)
- Calculated creatinine clearance of <30ml/min as per Cockcroft Gault equation
- Pregnancy (F)
- Post-menopausal (F)
- Current use of medications that can increase risk of renal dysfunction: diuretics, aminoglycosides

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 10231 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 291961 0
Self funded/Unfunded
Name [1] 291961 0
Country [1] 291961 0
Primary sponsor type
Individual
Name
Anne Trinh
Address
Hudson Institute of Medical Research
27-31 Wright St Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 290626 0
None
Name [1] 290626 0
Address [1] 290626 0
Country [1] 290626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293456 0
Monash HREC
Ethics committee address [1] 293456 0
Research Support Services
Level 2, I Block
Monash Health
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 293456 0
Australia
Date submitted for ethics approval [1] 293456 0
Approval date [1] 293456 0
13/08/2015
Ethics approval number [1] 293456 0
15353A

Summary
Brief summary
Broken bones and thin bones are common in people with cerebral palsy. This is due to a number of factors including reduced activity and standing, poor nutrition, use of medications for epilepsy and reduced sex hormones. Thin bones are becoming more of a problem as adults with cerebral palsy are getting older.


In older women and men with thin bones, there are good drug treatments available to reduce their risk of breaking a bone. One such treatment is zoledronic acid, which is given as an intravenous infusion once a year. This drug is currently being used and registered in Australia for treatment of osteoporosis (thin bones) in older women and men.

The aim of this study is to see if zoledronic acid can be used in adults with cerebral palsy to improve their bone strength and reduce their risk of breaking bones. This drug has not be used in a study of adults with cerebral palsy before.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60006 0
Dr Anne Trinh
Address 60006 0
Hudson Institute of Medical Research
27-31 Wright St Clayton, VIC, 3168
Country 60006 0
Australia
Phone 60006 0
+61395946666
Fax 60006 0
Email 60006 0
[email protected]
Contact person for public queries
Name 60007 0
Dr Anne Trinh
Address 60007 0
Hudson Institute of Medical Research
27-31 Wright St Clayton, VIC, 3168
Country 60007 0
Australia
Phone 60007 0
+61395946666
Fax 60007 0
Email 60007 0
[email protected]
Contact person for scientific queries
Name 60008 0
Dr Anne Trinh
Address 60008 0
Hudson Institute of Medical Research
27-31 Wright St Clayton, VIC, 3168
Country 60008 0
Australia
Phone 60008 0
+61395946666
Fax 60008 0
Email 60008 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.