The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients
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
Outcome
Met primary endpoint
paper There were statistically significant interactions between treatment effects and time for BMD measurements at the lumbar spine (P = 0.002) PMID 16490909 ↗
paper Differences in acute bone loss 3 months after transplantation favored zoledronic acid over placebo. PMID 16490909 ↗
paper CONCLUSION: Treatment with zoledronic acid can prevent bone loss within the first year after liver transplantation. PMID 16490909 ↗
Publications
- Background McDonald JA, Dunstan CR, Dilworth P, Sherbon K, Sheil AG, Evans RA, McCaughan GW. Bone loss after liver transplantation. Hepatology. 1991 Oct;14(4 Pt 1):613-9. doi: 10.1016/0270-9139(91)90047-y.
- Results Crawford BA, Kam C, Pavlovic J, Byth K, Handelsman DJ, Angus PW, McCaughan GW. Zoledronic acid prevents bone loss after liver transplantation: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2006 Feb 21;144(4):239-48. doi: 10.7326/0003-4819-144-4-200602210-00005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zoledronic acid | Other / unclassified | 4 mg | Intravenous |