Trial Review

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00575250




Registration number
NCT00575250
Ethics application status
Date submitted
17/12/2007
Date registered
18/12/2007
Date last updated
18/12/2007

Titles & IDs
Public title
Education for Osteoporosis in Persons With Existing Fractures
Scientific title
Osteoporosis Education Clinic Study
Secondary ID [1] 0 0
2.180405
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Osteoporosis Prevention and Self-Management Course
Behaviour - Introductory education session on osteoporosis

Active Comparator: 1 - Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours)

Active Comparator: 2 - One "introductory" osteoporosis education session (1 x 2 1/2 hours)


Behaviour: Osteoporosis Prevention and Self-Management Course
Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.

Behaviour: Introductory education session on osteoporosis
Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels
Timepoint [1] 0 0
Three and nine months
Secondary outcome [1] 0 0
Changes between baseline and three months within each group on osteoporosis knowledge, confidence in the ability to each calcium-containing foods and exercise, and the amount of calcium consumed in foods and exercise undertaken
Timepoint [1] 0 0
Three and nine months

Eligibility
Key inclusion criteria
- Presented to Modbury Hospital's Accident and Emergency Department with a new bone
fracture
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Residence in nursing home

- Fracture sustained in motor bike, push bike or motor vehicle accident

- Fracture sustained due to high trauma, such as fall from roof or ladder

- Dementia

- Inability to participate in group settings

- Inability to understand spoken English

- Inability to provide informed consent

- Pathological fracture

- Usual place of residence outside South Australia

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Modbury Hospital, Modbury - Adelaide
Recruitment postcode(s) [1] 0 0
5092 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Osteoporosis SA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education
intervention (the Osteoporosis Prevention and Self-Management Course), is different to one
session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing
foods, confidence to exercise, and amount of exercise undertaken after three and nine months
of follow-up in people aged over 50 years who have already had a bone fracture.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00575250
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laura L Laslett, MMedSci
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00575250