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 dataIdentifiers
Source Study
Trial name (public)
Zometa as a prophylactic treatment for bone mineral density loss in cancer patients following allogeneic stem cell transplantationTrial acronym
Not available
Trial ID
ACTRN12607000596404
Purpose
Prevention
Phase
Phase 2
Funding
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 .... Read more
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?
No
Population
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
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.
Comparison
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.
Outcomes
Outcome: Percent change in bone mineral density compared to baselineTimepoint: at day 100 and day 365 following allogeneic stem cell transplantation
Will individual participant data (IPD) for this trial be available?
yes
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