Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000583640
Ethics application status
Approved
Date submitted
27/09/2005
Date registered
4/10/2005
Date last updated
4/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
MRI to monitor the effect of zoledronic acid in erosive psoriatic arthritis
Scientific title
A randomised placebo controlled study to evaluate the effects of zoledronic acid in reducing the progression of erosions in psoriatic arthritis.
Secondary ID [1] 184 0
Protocol No. CZOL446HNZ02
Universal Trial Number (UTN)
Trial acronym
ZAPA study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic arthritis 710 0
Condition category
Condition code
Inflammatory and Immune System 787 787 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zoledronic acid for treatment of erosive psoriatic arthritis: double blind randomised placebo controlled study. One year duration ( 4 IV injections at 3 month intervals).
Intervention code [1] 680 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1003 0
To monitor MRI scans of dominant wrist and hand for change in bone erosion
Timepoint [1] 1003 0
Primary outcome [2] 1004 0
To monitor MRI scans of dominant wrist and hand for change in bone oedema score
Timepoint [2] 1004 0
Secondary outcome [1] 1890 0
To monitor change in Sharp score (hands and feet) - both total and separately the erosion score component.
Timepoint [1] 1890 0
Secondary outcome [2] 1891 0
To examine blood and urinary markers of bone turnover at 6 monthly intervals and compare these between the 2 groups.
Timepoint [2] 1891 0
Secondary outcome [3] 1892 0
To examine bone mineral density (BMD) in the two groups.
Timepoint [3] 1892 0
Secondary outcome [4] 1893 0
To examine osteoclast function at baseline and after 12 months in the 2 groups.
Timepoint [4] 1893 0

Eligibility
Key inclusion criteria
Psoriatic arthritis (according to Vasey and Espinoza criteria)Erosive PsA (bone lysis/ erosion peripheral joints on XR confirmed by a radiologist). Disease duration > 6 months. Suitable for MR scan* Adequate contraception if applicable DMARD, on a stable dose for 8 weeks prior to randomization Oral Prednisone no > 10mg daily at least 3 swollen and 3 tender joints.
Minimum age
20 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe kidney, liver or heart disease Deranged calcium or Vit D levelsUveitis, Iritis, or chronic Conjunctivitis (or history of these conditions)Diabetic eye or kidney disease Uncontrolled diabetes, Hb1AC > 10 % Cancer (metastatic cancer or cancer diagnosed < 2 years ago) Is pregnant or planning pregnancy Severe dental problems or current dental infection, recent or impending dental surgery within three months of enrolmentOrthopaedic surgery within 3 months of enrolment Fractures (within the last 3 months) Use of Bisphosphonate therapy Participant in any biologics trial within 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pharmacy supplied with random order list by statistician.Sequence was concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomised list was computer generated using a programme written in SAS.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 237 0
New Zealand
State/province [1] 237 0

Funding & Sponsors
Funding source category [1] 872 0
Charities/Societies/Foundations
Name [1] 872 0
Auckland Medical Research Foundation
Country [1] 872 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 738 0
Commercial sector/Industry
Name [1] 738 0
Novartis
Address [1] 738 0
Country [1] 738 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2151 0
Mutiregion ethics committee-Auckland Rotorua
Ethics committee address [1] 2151 0
Ethics committee country [1] 2151 0
New Zealand
Date submitted for ethics approval [1] 2151 0
Approval date [1] 2151 0
Ethics approval number [1] 2151 0
Ethics committee name [2] 2152 0
Mutiregion ethics committee-Wellington
Ethics committee address [2] 2152 0
Ethics committee country [2] 2152 0
New Zealand
Date submitted for ethics approval [2] 2152 0
Approval date [2] 2152 0
Ethics approval number [2] 2152 0

Summary
Brief summary
This study aims to investigate whether zoledronic acid is effective in slowing bone erosion/lysis in patients with psoriatic arthritis. ÿ¢ÿ¿ÿ¿ comparison with placebo. Bone damage to be assessed using MRI scans and XRays. Secondary outcomes assessed include BMD, ositeoclast function and bone turnover markers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35625 0
Address 35625 0
Country 35625 0
Phone 35625 0
Fax 35625 0
Email 35625 0
Contact person for public queries
Name 9869 0
Associate Professor Fiona McQueen
Address 9869 0
Department of Molecular Medicine and Pathology
University of Auckland
Private Bag 92019
Auckland
Country 9869 0
New Zealand
Phone 9869 0
+64 9 3737599
Fax 9869 0
+64 9 3754324
Email 9869 0
[email protected]
Contact person for scientific queries
Name 797 0
Cecelia Tong
Address 797 0
Department of Rheumatology
Greenlane Clinical Centre
Building 7
Greenlane West
Auckland 3
Country 797 0
New Zealand
Phone 797 0
+64 9 3797440 ext. 26671
Fax 797 0
Email 797 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.