A treatment algorithm evaluating the effect of zoledronic acid on bone mineral density loss after allogeneic stem cell transplantation (BM07)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 82 patients that had undergone bone marrow transplant Trial assessed the use of zoledronic acid as a treatment to reduce bone mineral density loss Demographic data, diagnostic data, treatment data, outcome data
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Source Study




Phase 2


Commercial sector/Industry,Novartis Pharmaceuticals Australia

Scientific enquiries

A/Prof Associate Professor Andrew Grigg

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 ....
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Key Inclusion Criteria

Patients agend 18 years or over undergoing allogeneic stem cell transplantation

Key Exclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performace status >1

Can healthy volunteers participate?




Sample Size    82

Min. age    18 Years

Max. age    0 Not stated

Sex    Both males and females

Condition category    Loss of bone mineral density in cancer patients whom have undergone allogeneic stem cell transplantation

Condition code    Cancer


Intervention code Prevention , Treatment: Drugs

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.


Control group Historical

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.


Outcome: Percent change in bone mineral density compared to baseline
Timepoint: at day 100 and day 365 following allogeneic stem cell transplantation

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see