OsteoporosisNCT00594789
Closing The Post Fracture Care Gap In Manitoba
A study testing Information letters in people with Osteoporosis, run by University of Manitoba at 1 site in Canada.
Trial summary
The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Information letters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,264 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women and men age 50 and older with one of the following fracture definitions:
- Hip fracture (physician ICD-9-CM 820-821 plus a procedure code for site-specific fracture reduction or fixation, open or closed)
- Spine fracture (physician ICD-9-CM code 805), or
- Humerus fracture (physician ICD-9-CM code 812), or
- Colles' fracture (physician ICD-9-CM code 813 plus a physician claim for site-specific fracture reduction or fixation, open or closed, or cast application).
Who cannot join
- Age less than 50.
- Non-Manitoba residents, cancelled Manitoba Health coverage, death or discharge to a personal care home.
- A fracture event in the previous 12 months meeting the study case definition (i.e., only a single notification per year is planned).
- Hip or wrist fractures without a procedure tariff.
- Current treatment with an osteoporosis medication.
- BMD testing within the preceding 3 years.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture. Post-fracture care often "falls between the cracks" when there is a breakdown in communication between hospital and community, or between specialists and primary care physicians. Often physicians and patients fail to make the connection between an acute fracture and osteoporosis, or the value of secondary prevention strategies. If untreated, there is an extremely high rate of additional fractures after a first osteoporotic fracture. It follows that improving BMD testing and/or treatment in appropriately identified individuals is a necessary step in optimizing post-fracture patient care. Over the next three years we will be testing and optimizing a notification procedure to physicians and/or patients relying upon fracture events reported to the provincial health service (Manitoba Health).
Read the detailed description
A major 'care gap' exists in the management of patients with fractures suggestive of osteoporosis. Currently, only a small minority of these individuals who are at high risk for recurrent fractures undergo evaluation for possible treatment. We propose to test and optimize a novel approach to address this question, relying upon fracture events reported to provincial health service (Manitoba Health) as a mechanism for osteoporosis case identification and enhancing post fracture care.
Phase 1 (one year duration): individuals meeting the fracture case definition will be randomized to usual care (no intervention), physician notification and physician/patient notification. The notification will provide a general recommendation for osteoporosis assessment. The use of appropriate post-fracture investigations and treatment will be prospectively evaluated.
Phase 2 (up to two years duration): the intervention will be refined and iteratively trialed for all individuals meeting the fracture case definition.
Phase 3: a recommendation for long term maintenance of the post-fracture intervention will be developed.
- Conditions
- Osteoporosis
- Being tested
- Information letters
- Keywords
- Osteoporosis, Fractures, Bone densitometry, Dual-energy x-ray absorptiometry
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information lettersOther
Information letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed.
| Study group | Role | What they receive |
|---|---|---|
| 1 (physician-only) | Experimental | Physician(s) connected with a fracture that meets study inclusion criteria. Receives: Other: Information letters |
| 2 (physician/patient) | Experimental | Physician(s) and patient connected with a fracture that meets study inclusion criteria. Receives: Other: Information letters |
| Control | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository.
Measured: 3 years (Phase 1 analysis at 1 year)
Secondary outcomes (3)
For individuals referred for BMD testing, an evaluation of treatment appropriateness will be performed based upon BMD results and 10-year fracture risk methods.
Measured: 3 years (Phase 1 analysis at 1 year)
Repeat fracture rates will be also studied as a secondary endpoint.
Measured: 3 years (Phase 1 analysis at 1 year)
An evaluation of post-fracture BMD testing and treatment rates in the years prior to the Phase 1 will also be performed to document practice patterns before the intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2011
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Manitoba Patient Access Network Steering Committee, The Manitoba Bone Density Program Committee
- Responsible party
- Principal investigator, William D. Leslie, University of Manitoba
- Investigators
- William D Leslie, MD MSc, Principal investigator, Faculty of Medicine, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594789
- Sponsor's protocol ID
- H2007:165
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2008
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Leslie WD, Metge C. Establishing a regional bone density program: lessons from the Manitoba experience. J Clin Densitom. 2003 Fall;6(3):275-82. doi: 10.1385/jcd:6:3:275.
PubMed 14514998Caetano PA, Labine L, Klassen P, Dreilich D, Leslie WD. Closing the postfracture care gap using administrative health databases: design and implementation of a randomized controlled trial. J Clin Densitom. 2011 Oct-Dec;14(4):422-7. doi: 10.1016/j.jocd.2011.04.008. Epub 2011 Jul 1.
PubMed 21723766Leslie WD, LaBine L, Klassen P, Dreilich D, Caetano PA. Closing the gap in postfracture care at the population level: a randomized controlled trial. CMAJ. 2012 Feb 21;184(3):290-6. doi: 10.1503/cmaj.111158. Epub 2011 Dec 19.
PubMed 22184366Majumdar SR, Lier DA, Leslie WD. Cost-effectiveness of two inexpensive postfracture osteoporosis interventions: results of a randomized trial. J Clin Endocrinol Metab. 2013 May;98(5):1991-2000. doi: 10.1210/jc.2013-1034. Epub 2013 Apr 17.
PubMed 23596140Cui Y, Lix LM, Yang S, Morin SN, Leslie WD. A population-based study of postfracture care in Manitoba, Canada 2000/2001-2014/2015. Osteoporos Int. 2019 Oct;30(10):2119-2127. doi: 10.1007/s00198-019-05074-8. Epub 2019 Jul 2.
PubMed 31267162
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing The Post Fracture Care Gap In Manitoba
- ClinicalTrials.gov ID
- NCT00594789
- Acronym / sponsor ID
- H2007:165
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Fractures, Bone densitometry, Dual-energy x-ray absorptiometry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,264 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- The Manitoba Patient Access Network Steering Committee, The Manitoba Bone Density Program Committee
- Study start
- Jun 2008 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2008 (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.
The objective of this study is to evaluate a post-fracture intervention for improving osteoporosis care in older men and women who have suffered a fracture that may indicate the presence of osteoporosis. Although osteoporosis can be identified with a bone mineral density (BMD) test, most individuals with osteoporosis are not diagnosed until they fracture. Post-fracture care often "falls between the cracks" when there is a breakdown in communication between hospital and community, or between specialists and primary care physicians. Often physicians and patients fail to make the connection between an acute fracture and osteoporosis, or the value of secondary prevention strategies. If untreated, there is an extremely high rate of additional fractures after a first osteoporotic fracture. It follows that improving BMD testing and/or treatment in appropriately identified individuals is a necessary step in optimizing post-fracture patient care. Over the next three years we will be testing and optimizing a notification procedure to physicians and/or patients relying upon fracture events reported to the provincial health service (Manitoba Health).
Detailed description
A major 'care gap' exists in the management of patients with fractures suggestive of osteoporosis. Currently, only a small minority of these individuals who are at high risk for recurrent fractures undergo evaluation for possible treatment. We propose to test and optimize a novel approach to address this question, relying upon fracture events reported to provincial health service (Manitoba Health) as a mechanism for osteoporosis case identification and enhancing post fracture care.
Phase 1 (one year duration): individuals meeting the fracture case definition will be randomized to usual care (no intervention), physician notification and physician/patient notification. The notification will provide a general recommendation for osteoporosis assessment. The use of appropriate post-fracture investigations and treatment will be prospectively evaluated.
Phase 2 (up to two years duration): the intervention will be refined and iteratively trialed for all individuals meeting the fracture case definition.
Phase 3: a recommendation for long term maintenance of the post-fracture intervention will be developed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 (physician-only) | Experimental | Other: Information lettersPhysician(s) connected with a fracture that meets study inclusion criteria. |
| 2 (physician/patient) | Experimental | Other: Information lettersPhysician(s) and patient connected with a fracture that meets study inclusion criteria. |
| Control | No intervention | –Usual care. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women and men age 50 and older with one of the following fracture definitions:
Key exclusion criteria (6 listed)
- Age less than 50.
- Non-Manitoba residents, cancelled Manitoba Health coverage, death or discharge to a personal care home.
- A fracture event in the previous 12 months meeting the study case definition (i.e., only a single notification per year is planned).
- Hip or wrist fractures without a procedure tariff.
- Current treatment with an osteoporosis medication.
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 |
|---|---|---|
| Information lettersInformation letters under Manitoba Health letterhead will be sent out to physician(s) and/or patient connected with a fracture that meets specific criteria. To address concerns over discontinuous care of patient seen at the time of fracture and for subsequent follow-up, the physician notification will specifically target the individual involved in the initial report to Manitoba Health as well as the primary care physician (using an algorithm developed by the Manitoba Centre for Health Policy). The notification will provide a general recommendation for osteoporosis assessment in addition to a copy of the BMD testing requisition since BMD testing is usually justified in this setting. The notification will not dictate what testing or treatment needs to be performed. | Other | 1 (physician-only), 2 (physician/patient) |
Primary outcome
Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository.
Time frame: 3 years (Phase 1 analysis at 1 year)
3 secondary outcomes
For individuals referred for BMD testing, an evaluation of treatment appropriateness will be performed based upon BMD results and 10-year fracture risk methods.
Time frame: 3 years (Phase 1 analysis at 1 year)
Repeat fracture rates will be also studied as a secondary endpoint.
Time frame: 3 years (Phase 1 analysis at 1 year)
An evaluation of post-fracture BMD testing and treatment rates in the years prior to the Phase 1 will also be performed to document practice patterns before the intervention.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 14514998Leslie WD, Metge C. Establishing a regional bone density program: lessons from the Manitoba experience. J Clin Densitom. 2003 Fall;6(3):275-82. doi: 10.1385/jcd:6:3:275.
- Background: PubMed 21723766Caetano PA, Labine L, Klassen P, Dreilich D, Leslie WD. Closing the postfracture care gap using administrative health databases: design and implementation of a randomized controlled trial. J Clin Densitom. 2011 Oct-Dec;14(4):422-7. doi: 10.1016/j.jocd.2011.04.008. Epub 2011 Jul 1.
- Results publication: PubMed 22184366Leslie WD, LaBine L, Klassen P, Dreilich D, Caetano PA. Closing the gap in postfracture care at the population level: a randomized controlled trial. CMAJ. 2012 Feb 21;184(3):290-6. doi: 10.1503/cmaj.111158. Epub 2011 Dec 19.
- Results publication: PubMed 23596140Majumdar SR, Lier DA, Leslie WD. Cost-effectiveness of two inexpensive postfracture osteoporosis interventions: results of a randomized trial. J Clin Endocrinol Metab. 2013 May;98(5):1991-2000. doi: 10.1210/jc.2013-1034. Epub 2013 Apr 17.
- Derived from this study: PubMed 31267162Cui Y, Lix LM, Yang S, Morin SN, Leslie WD. A population-based study of postfracture care in Manitoba, Canada 2000/2001-2014/2015. Osteoporos Int. 2019 Oct;30(10):2119-2127. doi: 10.1007/s00198-019-05074-8. Epub 2019 Jul 2.
- Manitoba BMD ProgramLink provided by the sponsor.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
William D Leslie, MD MSc principal investigator
Faculty of Medicine, University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information letters in people with Osteoporosis, run by University of Manitoba 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rates of BMD testing and/or osteoporosis pharmacotherapy in the year post-fracture using the population-based provincial administrative health data repository. (time frame: 3 years (Phase 1 analysis at 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594789, which also lists 5 linked publications.
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 1 May 2026.