ANZCTR - Registration

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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]

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

Serum periostin levels, following planned knee or hip joint replacement

Serum periostin levels, following open reduction internal fixation (ORIF) surgery

Condition category

Condition code

Injuries and Accidents

Fractures

Musculoskeletal

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]

Not applicable

Comparator / control treatment

N/A - observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Serum periostin levels over a six month period following a fracture

Timepoint [1]

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]

Investigation of potential associations between serum periostin and non-asthmatic health conditions (as captured by general health questionnaire e.g. diabetes)

Timepoint [1]

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?

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]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Genentech, Inc.

Address [1]

Genentech, Inc.
1 DNA Way, South San Francisco,
CA 94080-4990
USA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B HDEC

Ethics committee address [1]

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]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

15/01/2014

Ethics approval number [1]

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

Prof Richard Beasley

Address

Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242

Country

New Zealand

Phone

+64 4 805 0147

Fax

richard.beasley@mrinz.ac.nz

Contact person for public queries

Name

Rachel Caswell-Smith

Address

Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242

Country

New Zealand

Phone

+64 4 805 0247

Fax

rachel.caswell-smith@mrinz.ac.nz

Contact person for scientific queries

Name

Rachel Caswell-Smith

Address

Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242

Country

New Zealand

Phone

+64 4 805 0247

Fax

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

Source	Title	Year of Publication	DOI
Embase	Serum periostin levels following small bone fractures, long bone fractures and joint replacements: An observational study.	2018	https://dx.doi.org/10.1186/s13223-018-0254-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically