Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 283221 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 290094 0
Fracture risk communication 290095 0
Condition category
Condition code
Metabolic and Endocrine 290469 290469 0 0
Metabolic disorders
Musculoskeletal 290572 290572 0 0
Osteoporosis
Injuries and Accidents 290584 290584 0 0
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] 287950 0
Treatment: Other
Intervention code [2] 288029 0
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] 290494 0
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] 290494 0
3 months after the bone density scan and randomisation.
Secondary outcome [1] 304632 0
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] 304632 0
3 months after bone density scan and randomisation
Secondary outcome [2] 304860 0
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] 304860 0
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] 5414 0
New Zealand
State/province [1] 5414 0
Auckland

Funding & Sponsors
Funding source category [1] 287970 0
University
Name [1] 287970 0
University of Auckland
Country [1] 287970 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85, Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 286691 0
None
Name [1] 286691 0
None
Address [1] 286691 0
None
Country [1] 286691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289896 0
Health and Diability Ethics Committee
Ethics committee address [1] 289896 0
Ethics committee country [1] 289896 0
New Zealand
Date submitted for ethics approval [1] 289896 0
02/09/2013
Approval date [1] 289896 0
11/09/2013
Ethics approval number [1] 289896 0
13/CEN/127

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42974 0
Dr Ramanamma Kalluru
Address 42974 0
85, Park Road,
Bone and Joint Research group
Level 4, Building 502
University Auckland
Grafton
Auckland 1023
Country 42974 0
New Zealand
Phone 42974 0
+64 9 9234139
Fax 42974 0
Email 42974 0
[email protected]
Contact person for public queries
Name 42975 0
Ramanamma Kalluru
Address 42975 0
85, Park Road
Bone and Joint Research group
Level 4, Building 502
University Auckland
Grafton
Auckland 1023
Country 42975 0
New Zealand
Phone 42975 0
+64 9 9234139
Fax 42975 0
Email 42975 0
[email protected]
Contact person for scientific queries
Name 42976 0
Mark Bolland
Address 42976 0
85, Park Road,
Bone and Joint Research group
Level 4, Building 502
University Auckland
Grafton
Auckland 1023
Country 42976 0
New Zealand
Phone 42976 0
+64 9 9233004
Fax 42976 0
Email 42976 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
SourceTitleYear of PublicationDOI
EmbaseRandomised trial assessing the impact of framing of fracture risk and osteoporosis treatment benefits in patients undergoing bone densitometry.2017https://dx.doi.org/10.1136/bmjopen-2016-013703
N.B. These documents automatically identified may not have been verified by the study sponsor.