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Trial registered on ANZCTR


Registration number
ACTRN12614000151639
Ethics application status
Approved
Date submitted
30/01/2014
Date registered
7/02/2014
Date last updated
28/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine serum periostin levels over a six month period in adult patients, following a fracture
Scientific title
A study to determine serum periostin levels over a six month period in adult patients, following a short or long bone fracture, or undergoing hip or knee joint replacement, or open reduction internal fixation surgery
Secondary ID [1] 284006 0
Nil known
Universal Trial Number (UTN)
U1111-1150-0576
Trial acronym
PER04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum Periostin levels, following a fracture
 291042 0
Serum periostin levels, following planned knee or hip joint replacement 291075 0
Serum periostin levels, following open reduction internal fixation (ORIF) surgery 291076 0
Condition category
Condition code
Injuries and Accidents 291382 291382 0 0
Fractures
Musculoskeletal 291418 291418 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Serum Periostin levels
Serum Periostin levels will be measured at 7 time points: Baseline (within 48 hours of fracture occuring), Week 1, Week 2, Week 4, Week 8, Week 12 and 6 months post baseline, via a specific periostin laboratory assay.
For patients undergoing planned knee or hip joint replacement, an additional pre-operative sample will be taken at up to 3 months prior to Baseline
Intervention code [1] 288692 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291373 0
Serum periostin levels over a six month period following a fracture
Timepoint [1] 291373 0
Serum periostin will be measured at: Baseline (within 48 hours post fracture or surgery), week 1, week 2, week 4 , week 8, week 12 and 6 months post baseline.
For patients undergoing planned knee or hip joint replacement, an additional pre-operative sample will be taken at up to 3 months prior to Baseline
Secondary outcome [1] 306621 0
Investigation of potential associations between serum periostin and non-asthmatic health conditions (as captured by general health questionnaire e.g. diabetes)
Timepoint [1] 306621 0
Baseline visit (within 48 hours of fracture occuring)
For patients undergoing planned knee or hip joint replacement, the questionnaire will be administered at the pre-operative time point (up to 3 months prior to Baseline)

Eligibility
Key inclusion criteria
Aged between 18 to 75 years
Able to provide informed consent
Experienced a fracture to short or long bone less than 48 hours prior, or undergoing hip or knee joint replacement, or or open reduction internal fixation (ORIF) surgery
Participants will be enrolled to the following groups:
34 participants with a short-bone or phalangeal fracture
34 participants with a long bone fracture
34 participants undergoing hip or knee joint replacement surgery, or open reduction internal fixation (ORIF) surgery
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Doctor’s diagnosis of Asthma, Bronchitis or COPD
Wheezing or use of respiratory inhalers in the past 12 months
Known pregnancy
Significant co morbidities (determined at investigator discretion)
Hospital admission within last 3 months
Surgery within last 3 months, determined at investigator discretion (this includes all major surgery requiring general anaesthetic, dental extractions and root canal procedures. This does not include minor procedures, including but not limited to mole or wart removal, dental fillings etc).
Systemic Corticosteroids within the last 3 months
Any other safety concern at the investigator’s discretion

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
34 participants are sufficient to detect a paired difference in periostin of 0.5 of a standard deviation with 80% power. The conventional interpretation of an effect size of 0.5 of a standard deviation is of a medium effect size. For a comparison between large and small bone fractures a sample size of 68 has 90% power to detect a 0.8 standard deviation difference, a large effect size difference.
For analysis purposes the periostin levels will be plotted against time and a non-parametric scatter plot smoother will be used to determine if there is a pattern of variation with time that might be usefully explored with parametric regression (e.g. linear, quadratic, cubic time terms). Paired t-test and mixed linear models will be used to compare the six month periostin level with measurements at the other times to formally compare the change with time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/02/2014
Actual
21/05/2014
Date of last participant enrolment
Anticipated
31/12/2014
Actual
23/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
102
Recruitment outside Australia
Country [1] 5788 0
New Zealand
State/province [1] 5788 0
Wellington

Funding & Sponsors
Funding source category [1] 288630 0
Commercial sector/Industry
Name [1] 288630 0
Genentech, Inc.
Country [1] 288630 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Level 7 CSB, Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287337 0
None
Name [1] 287337 0
Address [1] 287337 0
Country [1] 287337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290487 0
Northern B HDEC
Ethics committee address [1] 290487 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 290487 0
New Zealand
Date submitted for ethics approval [1] 290487 0
Approval date [1] 290487 0
15/01/2014
Ethics approval number [1] 290487 0
13/NTB/186

Summary
Brief summary
Levels of POSTN (a protein-coding gene, also known as osteoblast specific factor) gene expression and periostin have been measured in a number of tissues and disease states and periostin has been shown to be present in the periosteum and periodontal ligament being critical for the formation and maintenance of bone and teeth.
Levels of POSTN gene expression following fracture have been measured but as serum periostin levels have not been measured following bone fractures it is difficult to determine the clinical significance of increased POSTN gene expression. This study endeavours to measure the serum periostin levels in participants with small bone and large bone fractures and in participants undergoing hip or knee joint replacements to determine if there are clinically significant changes in periostin levels following a fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38582 0
Prof Richard Beasley
Address 38582 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 38582 0
New Zealand
Phone 38582 0
+64 4 805 0147
Fax 38582 0
Email 38582 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 38583 0
Dr Rachel Caswell-Smith
Address 38583 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 38583 0
New Zealand
Phone 38583 0
+64 4 805 0247
Fax 38583 0
Email 38583 0
rachel.caswell-smith@mrinz.ac.nz
Contact person for scientific queries
Name 38584 0
Dr Rachel Caswell-Smith
Address 38584 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 38584 0
New Zealand
Phone 38584 0
+64 4 805 0247
Fax 38584 0
Email 38584 0
rachel.caswell-smith@mrinz.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseSerum periostin levels following small bone fractures, long bone fractures and joint replacements: An observational study.2018https://dx.doi.org/10.1186/s13223-018-0254-9
N.B. These documents automatically identified may not have been verified by the study sponsor.