Not available
ACTRN12607000596404
Prevention
Phase 2
Commercial sector/Industry,Novartis Pharmaceuticals Australia
A/Prof Associate Professor Andrew Grigg
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
Patients agend 18 years or over undergoing allogeneic stem cell transplantation
Eastern Cooperative Oncology Group (ECOG) performace status >1
No
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 baselineTimepoint: at day 100 and day 365 following allogeneic stem cell transplantation
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
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.
Any type of analysis Assessed on a case-by-case basis