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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Prince Alfred Hospital, Sydney, Australia
• Collaborator: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Greater than 17 years of age

Exclusion Criteria:

• Concurrent treatment, or within the past 12 months, with drugs known to affect bone metabolism

• Hypocalcemia

• Renal impairment (creatinine >1.5x ULN)