drugset / Trial / NCT00114556

The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients

NCT00114556

RandomizedSingle-groupDouble-blindPrevention

Summary

Following liver transplantation, rapid bone loss occurs, particularly within the first 6 months post-transplant. This may be associated with fractures, most notable vertebral. The ability to assess osteoporosis therapies in this system may provide useful information for osteoporosis management in general. Hypotheses: 1. That treatment with the bisphosphonate, zoledronate, at the time of liver transplantation and at 1 month post-transplantation will prevent the early transplant-related bone loss (measured by bone densitometry and biochemical bone markers at 3 months) seen in patients who are not treated with a bisphosphonate 2. That continuing treatment with zoledronate at 3 monthly intervals for a total duration of 12 months will result in further improvements in bone density beyond that seen at 3 months 3. That calcium and vitamin D (vit D) supplementation of liver transplant patients does not prevent marked bone loss following transplantation.

Timeline

Start
2000-02
Primary completion
Completion
2004-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronic acid Other / unclassified 4 mg Intravenous

Indications