Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000596404
Ethics application status
Approved
Date submitted
13/11/2007
Date registered
20/11/2007
Date last updated
4/08/2023
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Zometa as a prophylactic treatment for bone mineral density loss in cancer patients following allogeneic stem cell transplantation
Scientific title
A treatment algorithm evaluating the effect of zoledronic acid on bone mineral density loss after allogeneic stem cell transplantation
Secondary ID [1] 494 0
BM07 - Australasian Leukaemia and Lymphoma Group Trial Number
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loss of bone mineral density in cancer patients whom have undergone allogeneic stem cell transplantation 2545 0
Condition category
Condition code
Cancer 2645 2645 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zoledronic acid. 4mg dose administered intravenously. Dosing will occur in all patients within 7-days prior to the commencement of the conditioning regimen prior to stem cell transplantation, Zoledronic acid dosing will also occur following transplant at 3, 6, and 9 months if required.
Intervention code [1] 2277 0
Treatment: Drugs
Intervention code [2] 2292 0
Prevention
Comparator / control treatment
The comparator is no treatment. A historical group that did not receive prophylactic treatment for bone density loss while undergoing allogeneic stem cell transplantation will be used as controls.
Control group
Historical

Outcomes
Primary outcome [1] 3555 0
Percent change in bone mineral density compared to baseline
Timepoint [1] 3555 0
at day 100 and day 365 following allogeneic stem cell transplantation
Secondary outcome [1] 5953 0
A comparison of bone mineral density with historical controls
Timepoint [1] 5953 0
12-months post-alloSCT

Eligibility
Key inclusion criteria
Patients agend 18 years or over undergoing allogeneic stem cell transplantation
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Eastern Cooperative Oncology Group (ECOG) performace status >1

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
28/08/2008
Date of last participant enrolment
Anticipated
Actual
6/08/2013
Date of last data collection
Anticipated
Actual
10/08/2015
Sample size
Target
120
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 21710 0
New Zealand
State/province [1] 21710 0
Christchurch

Funding & Sponsors
Funding source category [1] 2790 0
Commercial sector/Industry
Name [1] 2790 0
Novartis Pharmaceuticals Australia
Country [1] 2790 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Australasian Leukaemia & Lymphoma Group
35 Elizabeth St, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 2520 0
None
Name [1] 2520 0
Address [1] 2520 0
Country [1] 2520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4709 0
Melbourne Health
Ethics committee address [1] 4709 0
The Royal Melbourne Hospital
City Campus
Level 2
PO Box 7000
South West
300 Grattan Street
Parkville Victoria, 3050
Ethics committee country [1] 4709 0
Australia
Date submitted for ethics approval [1] 4709 0
21/11/2007
Approval date [1] 4709 0
18/06/2008
Ethics approval number [1] 4709 0

Summary
Brief summary
A side-effect of allogeneic stem cell transplantation is a big loss in bone strength. Bone-strength is also called “bone mineral density” (BMD). One of the problems with a loss in bone strength is a higher risk of osteoporosis and bone fractures later in life. Hence, we are keen to look at ways by which this loss in bone-strength can be minimised.
A group of drugs, called bisphosphonates, have been shown to reduce the rate of bone-strength loss after transplants. The current study is a follow-on study that will will use a newer and more powerful bisphosphonate drug called zoledronic acid or Zometa®. Zometa® will be given to all patients before transplant but after transplant it will only be given to those patients whose bone mineral density (BMD) scan shows a >3% loss of bone density or to patients who receive large doses of prednisolone (steroid therapy). The aim is to use Zometa® only when it is needed.
The main measure of the success of the study is whether we can stop bone density loss, which will be calculated by comparing the results of the pre-transplant scan with those from the scans at day 100 and 12 months after the transplant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28180 0
A/Prof Andrew Grigg
Address 28180 0
C/- 4S, ONJCWC, 145 Studley Road, Heidelberg VIC 3084
Country 28180 0
Australia
Phone 28180 0
+61 3 94965093
Fax 28180 0
Email 28180 0
[email protected]
Contact person for public queries
Name 11337 0
A/Prof Associate Professor Andrew Grigg
Address 11337 0
C/- 4S, ONJCWC, 145 Studley Road, Heidelberg VIC 3084
Country 11337 0
Australia
Phone 11337 0
+61 3 94965093
Fax 11337 0
Email 11337 0
[email protected]
Contact person for scientific queries
Name 2265 0
A/Prof Associate Professor Andrew Grigg
Address 2265 0
C/- 4S, ONJCWC, 145 Studley Road, Heidelberg VIC 3084
Country 2265 0
Australia
Phone 2265 0
+61 3 94965093
Fax 2265 0
Email 2265 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to:
• Researchers from not-for-profit organisations
• Commercial organisations
• Other
Based in:
• Any location
Further information:
All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19912Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn individualised risk-Adapted protocol of pre-and post transplant zoledronic acid reduces bone loss after allogeneic stem cell transplantation: Results of a phase II prospective trial.2017https://dx.doi.org/10.1038/bmt.2017.108
N.B. These documents automatically identified may not have been verified by the study sponsor.