CompletedPhase 2ACTRN12607000596404

Zometa as a prophylactic treatment for bone mineral density loss in cancer patients following allogeneic stem cell transplantation

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


Sponsor

Australasian Leukaemia and Lymphoma Group

Enrollment

120 participants

Start Date

Aug 28, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates zometa as a prophylactic treatment for bone mineral density loss in cancer patients following allogeneic stem cell transplantation. It is open to aged 18 and older. To join, participants should meet criteria including: patients agend 18 years or over undergoing allogeneic stem cell transplantation. People who have eastern Cooperative Oncology Group (ECOG) performace status >1 may not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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, Zoledr

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.


Locations(1)

Christchurch, New Zealand

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ACTRN12607000596404