Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000512729
Ethics application status
Approved
Date submitted
6/05/2013
Date registered
8/05/2013
Date last updated
8/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to evaluate safety and feasibility of zoledronic acid to prevent joint complication (osteonecrosis) following chemotherapy for acute lymphoblastic leukemia or lymphoma in children and adolescents.
Scientific title
A pilot study to evaluate safety and feasibility of administrating prophylactic doses of zoledronic acid to prevent symptomatic osteonecrosis following chemotherapy for acute lymphoblastic leukemia and lymphoma in children and adolescents.
Secondary ID [1] 282442 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ZOL ALL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lymphoblastic leukemia 289051 0
Lymphoblastic lymphoma 289052 0
Osteonecrosis 289053 0
Condition category
Condition code
Cancer 289391 289391 0 0
Leukaemia - Acute leukaemia
Cancer 289392 289392 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Musculoskeletal 289393 289393 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 :2 doses of Zoledronic acid (0.025mg/kg/dose ,Intravenous infusion) will be administered to children more than 10 years of age at diagnosis of Acute lymphoblastic leukemia /lymphoblastic lymphoma. First dose will be administered on Day 8 of chemotherapy and second dose will be administered 6 weeks after that.Serial blood tests and radiological interventions will be carried out according to the protocol.
Group 2 : Includes children between 5-10 years of age.They do not get Zoledronic acid.Blood tests and radiological intervention will be carried out according to the prtocol.This is done to determine baseline incidence of osteonecrosis in this population.
Intervention code [1] 287086 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289501 0
To determine safety and feasibility of administering 2 doses of Intravenous Zoledronic acid to children, more than 10 years of age at diagnosis, with acute lymphoblastic leukemia and lymphoblastic lymphoma for prevention of symptomatic chemotherapy related osteonecrosis.
Blood tests and radiological investigations will be done at given time intervals.
Timepoint [1] 289501 0
Baseline
24 hours,48 hours,72hours after both interventions
At 4 months 1 year and 2 years after second dose of Zoledronic acid.
Secondary outcome [1] 302622 0
To determine effect of 2 doses of Zoledronic acid in children more than 10 years of age on development of symptomatic osteonecrosis.
MRI of hip and knee joints,X-rays of hips,knees and spine and pain scores(visual analogue scale) will be determined at set intervals.
Timepoint [1] 302622 0
At 4 months, 1 year and 2 year after intervention
Secondary outcome [2] 302623 0
To determine baseline incidence of symptomatic and asymptomatic osteonecrosis in children from 5 years-10 years of age.
MRI scans of hips and knee joints and X-rays of hips,knees and spine will be done at set interavals.
Timepoint [2] 302623 0
At 4 months, 1 year and 2 years from baseline
Secondary outcome [3] 302624 0
To determine effect of albumin and cholesterol level on development of osteonecrosis.
Albumin and cholesterol will be monitored at baseline.MRI scans and X rays of hips and knees will be doen to detect changes of osteonecrosis.
Timepoint [3] 302624 0
At 4 months, 1 year and 2 year after baseline.
Secondary outcome [4] 302625 0
To determine effect of 2 doses of zoledronic acid on bone mineral density.
DEXA scans will be done at set intervals.
Timepoint [4] 302625 0
baseline,1 year and 2 years
Secondary outcome [5] 302626 0
To collect samples and facilitate studies of genetic polymorphisms in the genes putatively related to development of osteonecrosis.
Blood sample will be collected at diagnosis.
Timepoint [5] 302626 0
2 years

Eligibility
Key inclusion criteria
1) Diagnosis of Acute lymphoblastic leukemia or lymphoblastic lymphoma
2) Age more than 10 years for Zoledronic acid intervention(group1)
3) Age between 5yr-10 yr and able to have MRI without general anaesthetic for investigations (group2)
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) 25 hydroxy vitamin D< 50 nmol/L
2) Hypocalcemia corrected for albumin
3) Prior bisphosphonate use
4) Estimated glomerular filtration rate (GFR) <35ml/min/1.73 m2 at screening based on Schwartz formula
5) Diagnosis of active uveitis
6) History of primary bone disease (osteogenesis imperfecta, idiopathic juvenile osteoporosis, rickets/osteomalacia)
7) Unable to have MRI without general anaesthesia

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 961 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 6819 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 287221 0
Hospital
Name [1] 287221 0
Oncology Department
The Childrens Hospital at Westmead
Country [1] 287221 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital Network
Address
Cnr Hawkesbury Road and hainsworth Street
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 285988 0
None
Name [1] 285988 0
Address [1] 285988 0
Country [1] 285988 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study is evaluating the safety and feasibility of zoledronic acid to prevent joint complication (osteonecrosis) following chemotherapy for acute lymphoblastic leukemia or lymphoma in children and adolescents.
Who is it for? You or your child may be eligible to join this study if you/they are aged between 5 and 16 years and have been diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Trial details: In participants more than 10 years of age the drug zoledronic acid will be intravenously infused (i.e. administered directly into the vein) on day 8 of chemotherapy and again 6 weeks later (Group 1). Children between 5-10 years of age will not receive zoledronic acid (Group 2). Both groups will be regularly monitored by blood tests and radiological interventions for up to 2 years post treatment in order to determine the feasibility and safety of zoledronic acid and the incidence of osteonecrosis (joint complication of cancer treatment).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39782 0
Dr Bhavna Padhye
Address 39782 0
Oncology Department
The Children's Hospital at Westmead
Cnr Hawkesbury road and hainsworth street
Westmead,NSW 2145
Country 39782 0
Australia
Phone 39782 0
+61298450000
Fax 39782 0
Email 39782 0
[email protected]
Contact person for public queries
Name 39783 0
Dr Bhavna Padhye
Address 39783 0
Oncology Department
The Children's Hospital at Westmead
Cnr Hawkesbury road and hainsworth street
Westmead,NSW 2145
Country 39783 0
Australia
Phone 39783 0
+61298450000
Fax 39783 0
Email 39783 0
[email protected]
Contact person for scientific queries
Name 39784 0
Dr Bhavna Padhye
Address 39784 0
Oncology Department
The Children's Hospital at Westmead
Cnr Hawkesbury road and hainsworth street
Westmead,NSW 2145
Country 39784 0
Australia
Phone 39784 0
+61298450000
Fax 39784 0
Email 39784 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.