OsteoporosisNCT00575250
Education for Osteoporosis in Persons With Existing Fractures
A study testing Osteoporosis Prevention and Self-Management Course and Introductory education session on osteoporosis in people with Osteoporosis, run by University of Adelaide at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Osteoporosis Prevention and Self-Management Course and Introductory education session on osteoporosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture
Who cannot join
- 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
Show all 9Show fewer
- Inability to provide informed consent
- Pathological fracture
- Usual place of residence outside South Australia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoporosis Education Clinic Study
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.
Read the detailed description
Instruments used to determine change after 3 and 9 months:
Osteoporosis knowledge: Osteoporosis Knowledge Assessment Test (Winzenberg et al. BMC Musculoskelet Disord 2003) Calcium intake: Food frequency questionnaire (Angus et al. J Am Diet Assoc 1989) Calcium and exercise self-efficacy: Osteoporosis Self-Efficacy Scale (Horan et al Res Nurs Health 1998) Physical activity: CHAMPS II (Stewart et al. J Gerontol A Biol Sci Med Sci 2001)
- Conditions
- Osteoporosis
- Being tested
- Osteoporosis Prevention and Self-Management Course, Introductory education session on osteoporosis
- Keywords
- Osteoporosis/prevention & control, Osteoporosis Prevention and Self-Management Course, Patient Education/*trends//Questionnaires, Adult//Aged//Middle Aged, Life Style//
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoporosis Prevention and Self-Management CourseBehavioural
Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.
Introductory education session on osteoporosisBehavioural
Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours) Receives: Behavioral: Osteoporosis Prevention and Self-Management Course |
| 2 | Active comparator | One "introductory" osteoporosis education session (1 x 2 1/2 hours) Receives: Behavioral: Introductory education session on osteoporosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels
Measured: Three and nine months
Secondary outcomes (1)
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
Measured: Three and nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- Osteoporosis SA
- Investigators
- Laura L Laslett, MMedSci, Principal investigator, University of AdelaideJulian D McNeil, PhD FRACP, Study chair, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575250
- Sponsor's protocol ID
- 2.180405
- Status last verified
- Dec 2007
- First submitted
- 17 Dec 2007
- Last updated
- 18 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Education Clinic Study
- ClinicalTrials.gov ID
- NCT00575250
- Acronym / sponsor ID
- 2.180405
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis/prevention & control, Osteoporosis Prevention and Self-Management Course, Patient Education/*trends//Questionnaires, Adult//Aged//Middle Aged, Life Style//
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- Osteoporosis SA
- Study start
- Jan 2004
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Instruments used to determine change after 3 and 9 months:
Osteoporosis knowledge: Osteoporosis Knowledge Assessment Test (Winzenberg et al. BMC Musculoskelet Disord 2003) Calcium intake: Food frequency questionnaire (Angus et al. J Am Diet Assoc 1989) Calcium and exercise self-efficacy: Osteoporosis Self-Efficacy Scale (Horan et al Res Nurs Health 1998) Physical activity: CHAMPS II (Stewart et al. J Gerontol A Biol Sci Med Sci 2001)
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Osteoporosis Prevention and Self-Management CourseOsteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours) |
| 2 | Active comparator | Behavioral: Introductory education session on osteoporosisOne "introductory" osteoporosis education session (1 x 2 1/2 hours) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteoporosis Prevention and Self-Management CourseFour weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader. | Behavioural | 1 |
| Introductory education session on osteoporosisIntroductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person. | Behavioural | 2 |
Primary outcome
Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels
Time frame: Three and nine months
1 secondary outcome
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
Time frame: Three and nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura L Laslett, MMedSci principal investigator
University of Adelaide
Julian D McNeil, PhD FRACP study chair
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoporosis Prevention and Self-Management Course and Introductory education session on osteoporosis in people with Osteoporosis, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels (time frame: Three and nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2007.