The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients
The Effect Of The Bisphosphonate, Zoledronic Acid, On Bone Density In Liver Transplant Patients - A Prospective, Randomised, Controlled Clinical Trial
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2000
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 15, 2005
CompletedFirst Posted
Study publicly available on registry
June 16, 2005
CompletedMay 9, 2006
December 1, 2004
June 15, 2005
May 8, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone density
Secondary Outcomes (1)
bone turnover markers
Interventions
Eligibility Criteria
You may qualify if:
- Greater than 17 years of age
You may not qualify if:
- Concurrent treatment, or within the past 12 months, with drugs known to affect bone metabolism
- Hypocalcemia
- Renal impairment (creatinine \>1.5x ULN)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Prince Alfred Hospital, Sydney, Australialead
- Novartiscollaborator
Study Sites (1)
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Related Publications (2)
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.
PMID: 1916662BACKGROUNDCrawford 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.
PMID: 16490909RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey McCaughan, PhD, MB BS
Royal Prince Alfred Hospital, Sydney, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 15, 2005
First Posted
June 16, 2005
Study Start
February 1, 2000
Study Completion
August 1, 2004
Last Updated
May 9, 2006
Record last verified: 2004-12