ANZCTR - Registration

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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]

CZOL446 AU02

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoporosis

Liver Transplantation

Fractures

Condition category

Condition code

Musculoskeletal

Osteoporosis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

bone density

Timepoint [1]

Secondary outcome [1]

bone turnover markers

Timepoint [1]

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?

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]

Royal Prince Alfred Hospital - Sydney

Recruitment postcode(s) [1]

2050 - Sydney

Funding & Sponsors

Primary sponsor type

Other

Name

Royal Prince Alfred Hospital, Sydney, Australia

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Novartis

Address [1]

Country [1]

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/study/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.
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.

Public notes

Contacts

Principal investigator

Name

Geoffrey McCaughan, PhD, MB BS

Address

Royal Prince Alfred Hospital, Sydney, Australia

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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

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

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

Trial Review

Registering a new trial?

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