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/study/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
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Crawford BA, Kam C, Pavlovic J, Byth K, Handelsman... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00114556