Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00114556




Registration number
NCT00114556
Ethics application status
Date submitted
15/06/2005
Date registered
16/06/2005
Date last updated
9/05/2006

Titles & IDs
Public title
The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients
Scientific title
The Effect Of The Bisphosphonate, Zoledronic Acid, On Bone Density In Liver Transplant Patients - A Prospective, Randomised, Controlled Clinical Trial
Secondary ID [1] 0 0
CZOL446 AU02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Liver Transplantation 0 0
Fractures 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - zoledronic acid

Treatment: Drugs: zoledronic acid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
bone density
Timepoint [1] 0 0
Secondary outcome [1] 0 0
bone turnover markers
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Greater than 17 years of age
Minimum age
17 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Concurrent treatment, or within the past 12 months, with drugs known to affect bone
metabolism

- Hypocalcemia

- Renal impairment (creatinine >1.5x ULN)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Prince Alfred Hospital, Sydney, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00114556
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Geoffrey McCaughan, PhD, MB BS
Address 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00114556