ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613001081707

Ethics application status

Approved

Date submitted

19/09/2013

Date registered

26/09/2013

Date last updated

15/10/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Exploring the effects of different ways of communicating fracture risk and treatment benefits would influence patients' beliefs of risk of fracture and osteoporosis treatment to reduce their fracture risk.

Scientific title

The effect of different approaches to communicating fracture risk to adults on their perceived risk of osteoporotic fracture and hip fracture at which treatment would be considered.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Osteoporosis

Fracture risk communication

Condition category

Condition code

Metabolic and Endocrine

Metabolic disorders

Musculoskeletal

Osteoporosis

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will complete a questionnaire regarding clinical history, have their bone density measured, and then complete a short questionnaire exploring their beliefs about their risk of fracture and the benefits they might obtain from treatment. Their absolute risk of osteoporotic fracture and hip fracture within the next 5 years will be calculated. Participants will then be randomised to receive one of four different presentations of their absolute risk, and the likely benefits they could expect from osteoporosis treatment (option 1: framed as the chance of having an event, option 2: the chance of not having an event, option 3: the number needed to treat to prevent an event, and option 4: the number needed to treat to prevent an event, with presentation of number treated without benefit).
Participants will then complete a short questionnaire (immediately and at 3 months) exploring whether the knowledge of their absolute risk of fracture has influenced their beliefs about their personal risk of fracture, their willingness to take treatment, and the benefits of treament.
All the questionnaires are administered as a written information.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

All 4 groups with 4 differents presentaions of fracture risk and treatment benefits are compared.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is the perceived risk of total fracture and hip fracture at which treatment would be considered. The primary outcome is assessed by administering questionnaires at the time of bone density scan, 3 months after their bone density scan and randomisation.

Timepoint [1]

3 months after the bone density scan and randomisation.

Secondary outcome [1]

Perceived need for treatment, assessed by administering questionnaire at the time of bone density scan and 3 months after the bone density scan and randomisation.

Timepoint [1]

3 months after bone density scan and randomisation

Secondary outcome [2]

Perceived threshold for fracture, assessed by administering questionnaire at the time of bone density scan and 3 months after the bone density scan and randomisation.

Timepoint [2]

3 months after bone density scan and randomisation

Eligibility

Key inclusion criteria

Age >60y (because the Garvan absolute fracture risk calculator does not estimate fracture risk for younger participants).

Minimum age

60 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Patients taking antiresorptive treatment for osteoporosis.
Unable to complete the questionnaires, for language or cognitive reasons

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)

200 consecutive English speaking patients > 60 years of age, attending the University of Auckland bone densitometry service will be recruited after written informed consent. Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomised as per computer generated random numbers to one of the four different ways of presenting risk of fracture and treatment benefits.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

The primary analysis will be a comparison between the four randomised groups for the perceived risks of total fracture and hip fracture at which treatment would be considered. Secondary analyses will be comparisons between the four groups for the perceived risk of fracture, the perceived need for treatment, the perceived thresholds for risk of fracture, and comparisons between the baseline data and the data post provision of the participant’s risk of fracture will be undertaken for all of these variables. Differences in continuous variables will be tested with one way ANOVA or t-tests as appropriate, and differences in categorical tests tested using chi-square tests or McNemar’s test.

This is a novel study and it is difficult to estimate what effect sizes we will observe. Therefore a power calculation is problematic. We estimate that recruiting 200 patients is feasible and can be achieved in a timely period (< 3 months). With 50 patients per group, the largest confidence interval for a percentage result is 14% (when the result is 50%). Thus, a difference of approximately 20% could be detected in a pairwise comparison between 2 groups in this scenario. If the result was closer to 100% or 0%, the detectable difference becomes smaller.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/10/2013

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland

Address [1]

85, Park Road
Grafton
Auckland
New Zealand 1023

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Auckland

Address

85, Park Road
Grafton
Auckland 1023

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Diability Ethics Committee

Ethics committee address [1]

1 The Terrace
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]

02/09/2013

Approval date [1]

11/09/2013

Ethics approval number [1]

13/CEN/127

Summary

Brief summary

Osteoporosis (thin bones) is a common disorder in New Zealand. Having thin bones increases the chance that a fracture (broken bone) will occur. Prevention of fracture is currently best achieved by identifying those people at higher risk of fracture and treating them with medications that are known to reduce fracture risk.
Effective communication of information about risk is therefore very important in managing bone health. There are different ways of presenting information about risk- for example, risk can be framed positively (you have a 5% chance of a particular outcome) or negatively (you have a 95% chance of NOT having that outcome), or can be presented using any of several numerical methods. Our study aims to explore the presenting risk in different ways on people's attitudes to, and beliefs about, bone health.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ramanamma Kalluru

Address

85, Park Road,
Bone and Joint Research group
Level 4, Building 502
University Auckland
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 9 9234139

Fax

r.kalluru@auckland.ac.nz

Contact person for public queries

Name

Ramanamma Kalluru

Address

85, Park Road
Bone and Joint Research group
Level 4, Building 502
University Auckland
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 9 9234139

Fax

r.kalluru@auckland.ac.nz

Contact person for scientific queries

Name

Mark Bolland

Address

85, Park Road,
Bone and Joint Research group
Level 4, Building 502
University Auckland
Grafton
Auckland 1023

Country

New Zealand

Phone

+64 9 9233004

Fax

m.bolland@auckland.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	Randomised trial assessing the impact of framing of fracture risk and osteoporosis treatment benefits in patients undergoing bone densitometry.	2017	https://dx.doi.org/10.1136/bmjopen-2016-013703

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