Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12608000529347
Ethics application status
Approved
Date submitted
28/08/2008
Date registered
15/10/2008
Date last updated
15/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Screening for Osteoporosis; Australian Primary Care Evaluation of Clinical Tests
Scientific title
The prevalence of osteoporosis and vertebral fractures in a primary care setting assessed by clinical and radiology tests
Secondary ID [1] 685 0
Nil
Universal Trial Number (UTN)
Trial acronym
PROSPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 3617 0
Condition category
Condition code
Musculoskeletal 3775 3775 0 0
Osteoporosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross sectional survey to identify the prevalence of osteoporosis, the prevelance of vertebral fractures in the Australian primary care setting. General Practitioners (GPs) completed a case report form for consecutive patients who were 70 years of age and over and did not have a previous diagnosis of osteoporosis. The case report form included patient demographics, medical history, medications, clinical tests etc. and took approximately 10 minutes to complete. GPs refer patients for a Dual-energy X-ray Absorptiometry (DEXA) and verterbral X-ray scan at local I-med radiology centres, participating in the study. Second x-ray readings are performed by a single radiologist. The data is collected prospectively over a period of 6 months with GPs participating in the study for the same length of time.
Intervention code [1] 3291 0
Not applicable
Intervention code [2] 3329 0
Early detection / Screening
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4670 0
The prevalance of osteoporosis and verterbral fracture in a primary care setting, will be determined using the reports from radiology tests.
Timepoint [1] 4670 0
14 November 2008, study close: all patient data submitted for analysis
Secondary outcome [1] 7892 0
Examine predictors of osteoporosis and fracture using the survey data provided and a logistical regression model.
Timepoint [1] 7892 0
End of December 2008: Database lock

Eligibility
Key inclusion criteria
Women aged 70 years and over, who have not had a previous diagnosis of osteoporosis.
Minimum age
70 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to read or give informed consent in English; previous diagnosis of osteoporosis; a history of a DEXA scan in the last 2 years; significant chronic disease that in itself is an indication for the patient to have a DEXA scan, a history of more than 6 months use of raloxifene, bisphosphonate, strontium ranelate, 1,25 vitamin D or parathyroid hormone (PTH) analogue; use of systemic hormone replacement therapy (HRT) within the last 2 years.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3794 0
Commercial sector/Industry
Name [1] 3794 0
Servier Laboratories
Country [1] 3794 0
Australia
Primary sponsor type
Individual
Name
Prof Leon Piterman AM
Address
Department of General Practice
Monash University
Building 1, 270 Ferntree Gully Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 3404 0
None
Name [1] 3404 0
Address [1] 3404 0
Country [1] 3404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5853 0
Standing Committee on Ethics in Research involving Humans (SCERH)
Ethics committee address [1] 5853 0
Human Ethics Office
First Floor, Building 3E, Room 111
Monash University VIC 3800
Ethics committee country [1] 5853 0
Australia
Date submitted for ethics approval [1] 5853 0
Approval date [1] 5853 0
14/03/2008
Ethics approval number [1] 5853 0
CF08/0155-2008000030

Summary
Brief summary
This study will assess how a sample group of approximately 4000 elderly patients are being screened and daignosed for osteoporosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28859 0
Address 28859 0
Country 28859 0
Phone 28859 0
Fax 28859 0
Email 28859 0
Contact person for public queries
Name 12016 0
Dr Andrew Weekes
Address 12016 0
8 Cato Street
Hawrthorn VIC 3122
Country 12016 0
Australia
Phone 12016 0
1800 654 311
Fax 12016 0
03 9822 4190
Email 12016 0
[email protected]
Contact person for scientific queries
Name 2944 0
Dr Andrew Weekes
Address 2944 0
8 Cato Street
Hawthorn VIC 3122
Country 2944 0
Australia
Phone 2944 0
1800 654 311
Fax 2944 0
03 9822 4190
Email 2944 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.