ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

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]

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

Condition category

Condition code

Cancer

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]

Treatment: Drugs

Intervention code [2]

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]

Percent change in bone mineral density compared to baseline

Timepoint [1]

at day 100 and day 365 following allogeneic stem cell transplantation

Secondary outcome [1]

A comparison of bone mineral density with historical controls

Timepoint [1]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Novartis Pharmaceuticals Australia

Address [1]

54 Waterloo Road, North Ryde, NSW, 2113

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

The Royal Melbourne Hospital 
City Campus
Level 2
PO Box 7000
South West
300 Grattan Street
Parkville Victoria, 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2007

Approval date [1]

18/06/2008

Ethics approval number [1]

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

A/Prof Andrew Grigg

Address

C/- 4S, ONJCWC, 145 Studley Road, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 94965093

Fax

andrew.grigg@austin.org.au

Contact person for public queries

Name

Associate Professor Andrew Grigg

Address

C/- 4S, ONJCWC, 145 Studley Road, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 94965093

Fax

andrew.grigg@austin.org.au

Contact person for scientific queries

Name

Associate Professor Andrew Grigg

Address

C/- 4S, ONJCWC, 145 Studley Road, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 94965093

Fax

andrew.grigg@austin.org.au

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 info@allg.org.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19912	Study protocol			info@allg.org.au	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

Source	Title	Year of Publication	DOI
Embase	An 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.	2017	https://dx.doi.org/10.1038/bmt.2017.108

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically