OsteoporosisNCT00226031
Optimal Management of Women With Wrist Fractures
A study testing Educational Material and Reminder in people with Osteoporosis and Osteopenia, run by Queen's University at 1 site in Canada.
Trial summary
To evaluate the effectiveness of a multifaceted intervention (reminder and educational material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women with wrist fractures by their primary care physicians. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Educational Material and Reminder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2003to Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray).
- Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy .
Who cannot join
- Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture).
- Significant cognitive impairment (which would preclude them from filling out simple questionnaires).
- Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Management of Older Women With Distal Forearm Fractures
To evaluate the effectiveness of a multifaceted intervention (reminder and educational material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women with wrist fractures by their primary care physicians. The intervention is directed at improving the gap in continuity of care between emergency/fracture clinics and family physicians, and reducing knowledge gaps.
Read the detailed description
Numerous studies have demonstrated that women with wrist fractures have lower bone mineral density. Despite new guidelines for the care of such women, research has shown that they are not generally evaluated for osteoporosis. This care gap exists although it is known that wrist fractures are an important marker for subsequent fractures, such as a hip fracture, which represents a significant socio-economic burden to society.
Comparison: Cluster randomized trial of women and their physicians, both of whom receive educational material and reminder on post fracture osteoporosis evaluation. Comparison is to women and their physicians who receive standard post fracture information. Family practices are randomized to intervention or non-intervention group.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Educational Material and Reminder
- Keywords
- Osteoporosis, Wrist fractures, Knowledge translation, Implementation, Educational reminder
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Material and ReminderProcedure or surgery
Family practices were randomly assigned to intervention or usual care. The intervention was a mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the GP and a letter and educational package for the women.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Usual care. Receives: Procedure: Educational Material and Reminder |
| 2 | Experimental | Mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the family physician and a letter and educational package for the women. Receives: Procedure: Educational Material and Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture.
Measured: 6 months
Secondary outcomes (2)
Proportion of women in whom a bone density scan is ordered and the proportion of women who receive counseling advice about osteoporosis from their family physicians.
Measured: 6 months
Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2006
- Study completionAug 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Ann B Cranney, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226031
- Sponsor's protocol ID
- KTS-62358
- Status last verified
- Mar 2015
- First submitted
- 22 Sep 2005
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Management of Older Women With Distal Forearm Fractures
- ClinicalTrials.gov ID
- NCT00226031
- Acronym / sponsor ID
- KTS-62358
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, Wrist fractures, Knowledge translation, Implementation, Educational reminder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 26 Sep 2005 (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.
To evaluate the effectiveness of a multifaceted intervention (reminder and educational material) in improving the evaluation of osteoporosis follow-up care of post-menopausal women with wrist fractures by their primary care physicians. The intervention is directed at improving the gap in continuity of care between emergency/fracture clinics and family physicians, and reducing knowledge gaps.
Detailed description
Numerous studies have demonstrated that women with wrist fractures have lower bone mineral density. Despite new guidelines for the care of such women, research has shown that they are not generally evaluated for osteoporosis. This care gap exists although it is known that wrist fractures are an important marker for subsequent fractures, such as a hip fracture, which represents a significant socio-economic burden to society.
Comparison: Cluster randomized trial of women and their physicians, both of whom receive educational material and reminder on post fracture osteoporosis evaluation. Comparison is to women and their physicians who receive standard post fracture information. Family practices are randomized to intervention or non-intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Educational Material and ReminderUsual care. |
| 2 | Experimental | Procedure: Educational Material and ReminderMailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the family physician and a letter and educational package for the women. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray).
- Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy .
Key exclusion criteria (3 listed)
- Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture).
- Significant cognitive impairment (which would preclude them from filling out simple questionnaires).
- Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene).
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 |
|---|---|---|
| Educational Material and ReminderFamily practices were randomly assigned to intervention or usual care. The intervention was a mailed reminder with a summary of osteoporosis screening and treatment guidelines sent to the GP and a letter and educational package for the women. | Procedure or surgery | 1, 2 |
Primary outcome
Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture.
Time frame: 6 months
2 secondary outcomes
Proportion of women in whom a bone density scan is ordered and the proportion of women who receive counseling advice about osteoporosis from their family physicians.
Time frame: 6 months
Women's knowledge about osteoporosis and fractures (Osteoporosis Knowledge Questionnaire).
Time frame: 6 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 11 Mar 2015.
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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.
Ann B Cranney, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Material and Reminder in people with Osteoporosis and Osteopenia, run by Queen's University at 1 site in Canada.
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 2 inclusion and 3 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 11 Mar 2015. 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 Canada. 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?
Proportion of women who are prescribed anti-osteoporosis therapy within 6 months of sustaining a forearm fracture. (time frame: 6 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 11 Mar 2015.