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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000596404
Enrollment
82
Registered
2007-11-20
Start date
2008-08-28
Completion date
2013-08-06
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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, Zoledronic acid dosing will also occur following transplant at 3, 6, and 9 months if required.

Sponsors

Australasian Leukaemia and Lymphoma Group
Lead SponsorOther Collaborative groups

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients agend 18 years or over undergoing allogeneic stem cell transplantation

Exclusion criteria

Eastern Cooperative Oncology Group (ECOG) performace status >1

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026