OsteoporosisC-STOP#NCT01401556
C-STOP Fracture Trial
A study testing case management and Multifaceted quality improvement intervention in people with Osteoporosis, run by University of Alberta at 1 site in Canada.
Trial summary
The objective of the proposed research is to improve quality of care for older outpatients who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist or other upper extremity fracture. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- case management and Multifaceted quality improvement intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Apr 2022
- 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
- age 50 years or greater
- any forearm (distal radius or ulna, "wrist") or arm (proximal humerus, "upper arm") fracture
Who cannot join
- unable to give simple informed consent or unwilling to participate in the study
- unable to understand, read, and converse in English
- presence of pathological (e.g., cancer related) or multiple (e.g., major trauma) fractures
- already treated for osteoporosis with a bisphosphonate
- residence in a nursing home or from outside Edmonton
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Strategies Targeting Osteoporosis to Prevent Recurrent Fractures: C-STOP# Randomized Trial
The objective of the proposed research is to improve quality of care for older outpatients who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist or other upper extremity fracture. Although most of these patients warrant evidence-based and guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate treatment rates less than 10-20% in the year post-fracture. Several trials, including the investigators own prior studies, have tried to address this osteoporosis care-gap and have reported that various multifaceted interventions (combinations of patient and physician education, guidelines, and physician reminders) can modestly improve treatment rates compared with usual care, although 60-70% of the patients exposed to these interventions still remain untreated. The investigators believe that a case-manager (who identifies and independently sees patients in clinic, arranges bone mineral density [BMD] tests, and offers guideline-based treatment to those with low BMD) represents a potential solution that holds great promise.
The investigators hypothesize that an osteoporosis case-manager will effectively and efficiently increase rates of osteoporosis treatment in older outpatients with upper extremity fractures when compared with a documented effective and cost-saving multifaceted intervention. To test this hypothesis the investigators propose a pragmatic patient-level randomized controlled comparative effectiveness trial with blinded outcomes ascertainment that compares the case-manager strategy with the multifaceted intervention.
Read the detailed description
Objective: To improve treatment of osteoporosis in older patients with upper extremity fractures.
Background: Osteoporosis causes low bone mass and skeletal fragility leading to fractures of the hip, spine, and upper extremity that cause pain, deformity, disability, and even death. It affects 2 million older Canadians and costs us a billion dollars a year. Guidelines recommend aggressive treatment in older patients with osteoporosis-related fractures because risk of another fracture is 20% within 1-year and because bisphosphonate treatment reduces fracture risk by 50%. Unfortunately, less than 10% of older outpatients are treated for osteoporosis in the year post-fracture and even the most effective multifaceted interventions tested so far (i.e., combinations of patient education with physician guidelines and reminders) have only increased post-fracture osteoporosis treatment rates with bisphosphonates to 22%.
Proposed Strategy: Osteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD.
Hypothesis: An osteoporosis case-manager will effectively and efficiently increase rates of BMD testing and bisphosphonate treatment in older high-risk patients with upper extremity fractures compared with a previously tested effective and cost-saving multifaceted osteoporosis intervention (an active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians).
Specific Aims: To determine whether an osteoporosis case-manager strategy can:
- Increase rates of osteoporosis treatment more than a multifaceted intervention
- Increase rates of BMD testing more than a multifaceted intervention
- Be cost-effective when compared with either multifaceted intervention or usual care
Study Design: Randomized controlled comparative effectiveness trial with blinded (allocation-concealed) ascertainment of outcomes comparing case-managers to the multifaceted intervention. Eligible patients will be 50 years and older with an upper extremity fracture and not already treated with bisphosphonates, recruited from Emergency Departments and Fracture Clinics. Primary outcome will be the proportion starting bisphosphonates within 6-months. Secondary outcomes include BMD testing, any osteoporosis treatment, and appropriate care. Case-managers are expected to increase bisphosphonate treatment rates to 43% (achieved in our pilot trial) vs published multifaceted intervention rates of 22%. With alpha=0.05, beta=0.9, and 10% attrition rates, the total minimum required sample size is 240 patients. Using 1-year outcomes and micro-costing data from the trial and our published Markov decision analytic model for osteoporosis quality improvement interventions, the incremental costs and effectiveness of the case-manager will then be compared to both the multifaceted intervention and usual care. Major secondary outcome includes long-term treatment persistence, and to examine this question (e.g., 80% persistence rates with case-manager vs 50% persistence with multifaceted intervention) will require a sample size of at least 360 patients.
- Conditions
- Osteoporosis
- Being tested
- case management, Multifaceted quality improvement intervention
- Keywords
- osteoporosis, fracture, treatment, guidelines, quality
- 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.
case managementOther
Multifaceted quality improvement interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Case Manager Intervention | Experimental | Osteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD. Receives: Other: case management |
| Multifaceted quality improvement intervention | Active comparator | Active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians Receives: Other: Multifaceted quality improvement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of untreated patients newly starting prescription osteoporosis treatment with a bisphosphonate after their fracture
Proportion of previously untreated patients (%) newly starting prescription osteoporosis treatment with a bisphosphonate within 6-months of an upper extremity fragility fracture
Measured: 6-months
Secondary outcomes (1)
New Treatment Persistence
Of those newly starting treatment, what proportion are still persisting with it at 1-year of followup
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 posted25 Jul 2011 (estimated)
- Study startSep 2012
- Primary completionDec 2019
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumit R Majumdar, MD, MPH, Principal investigator, University of AlbertaCarrie Ye, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401556
- Sponsor's protocol ID
- Pro00018520
- Acronym
- C-STOP#
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2011
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Majumdar SR, Johnson JA, Bellerose D, McAlister FA, Russell AS, Hanley DA, Garg S, Lier DA, Maksymowych WP, Morrish DW, Rowe BH. Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study. Osteoporos Int. 2011 Jan;22(1):223-30. doi: 10.1007/s00198-010-1212-7. Epub 2010 Apr 1.
PubMed 20358359Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH. Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial. CMAJ. 2008 Feb 26;178(5):569-75. doi: 10.1503/cmaj.070981.
PubMed 18299546McAlister FA, Ye C, Beaupre LA, Rowe BH, Johnson JA, Bellerose D, Hassan I, Majumdar SR. Adherence to osteoporosis therapy after an upper extremity fracture: a pre-specified substudy of the C-STOP randomized controlled trial. Osteoporos Int. 2019 Jan;30(1):127-134. doi: 10.1007/s00198-018-4702-7. Epub 2018 Sep 19.
PubMed 30232538
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Strategies Targeting Osteoporosis to Prevent Recurrent Fractures: C-STOP# Randomized Trial
- ClinicalTrials.gov ID
- NCT01401556
- Acronym / sponsor ID
- C-STOP# / Pro00018520
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, fracture, treatment, guidelines, quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 25 Jul 2011 (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 the proposed research is to improve quality of care for older outpatients who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist or other upper extremity fracture. Although most of these patients warrant evidence-based and guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate treatment rates less than 10-20% in the year post-fracture. Several trials, including the investigators own prior studies, have tried to address this osteoporosis care-gap and have reported that various multifaceted interventions (combinations of patient and physician education, guidelines, and physician reminders) can modestly improve treatment rates compared with usual care, although 60-70% of the patients exposed to these interventions still remain untreated. The investigators believe that a case-manager (who identifies and independently sees patients in clinic, arranges bone mineral density [BMD] tests, and offers guideline-based treatment to those with low BMD) represents a potential solution that holds great promise.
The investigators hypothesize that an osteoporosis case-manager will effectively and efficiently increase rates of osteoporosis treatment in older outpatients with upper extremity fractures when compared with a documented effective and cost-saving multifaceted intervention. To test this hypothesis the investigators propose a pragmatic patient-level randomized controlled comparative effectiveness trial with blinded outcomes ascertainment that compares the case-manager strategy with the multifaceted intervention.
Detailed description
Objective: To improve treatment of osteoporosis in older patients with upper extremity fractures.
Background: Osteoporosis causes low bone mass and skeletal fragility leading to fractures of the hip, spine, and upper extremity that cause pain, deformity, disability, and even death. It affects 2 million older Canadians and costs us a billion dollars a year. Guidelines recommend aggressive treatment in older patients with osteoporosis-related fractures because risk of another fracture is 20% within 1-year and because bisphosphonate treatment reduces fracture risk by 50%. Unfortunately, less than 10% of older outpatients are treated for osteoporosis in the year post-fracture and even the most effective multifaceted interventions tested so far (i.e., combinations of patient education with physician guidelines and reminders) have only increased post-fracture osteoporosis treatment rates with bisphosphonates to 22%.
Proposed Strategy: Osteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD.
Hypothesis: An osteoporosis case-manager will effectively and efficiently increase rates of BMD testing and bisphosphonate treatment in older high-risk patients with upper extremity fractures compared with a previously tested effective and cost-saving multifaceted osteoporosis intervention (an active-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians).
Specific Aims: To determine whether an osteoporosis case-manager strategy can:
- Increase rates of osteoporosis treatment more than a multifaceted intervention
- Increase rates of BMD testing more than a multifaceted intervention
- Be cost-effective when compared with either multifaceted intervention or usual care
Study Design: Randomized controlled comparative effectiveness trial with blinded (allocation-concealed) ascertainment of outcomes comparing case-managers to the multifaceted intervention. Eligible patients will be 50 years and older with an upper extremity fracture and not already treated with bisphosphonates, recruited from Emergency Departments and Fracture Clinics. Primary outcome will be the proportion starting bisphosphonates within 6-months. Secondary outcomes include BMD testing, any osteoporosis treatment, and appropriate care. Case-managers are expected to increase bisphosphonate treatment rates to 43% (achieved in our pilot trial) vs published multifaceted intervention rates of 22%. With alpha=0.05, beta=0.9, and 10% attrition rates, the total minimum required sample size is 240 patients. Using 1-year outcomes and micro-costing data from the trial and our published Markov decision analytic model for osteoporosis quality improvement interventions, the incremental costs and effectiveness of the case-manager will then be compared to both the multifaceted intervention and usual care. Major secondary outcome includes long-term treatment persistence, and to examine this question (e.g., 80% persistence rates with case-manager vs 50% persistence with multifaceted intervention) will require a sample size of at least 360 patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Manager Intervention | Experimental | Other: case managementOsteoporosis case-managers will identify older fracture patients in Emergency Departments and Fracture Clinics; arrange bone mineral density (BMD) tests; meet with patients to counsel them and go over their results; and then offer and prescribe bisphosphonate treatment to those with low BMD. |
| Multifaceted quality improvement intervention | Active comparator | Other: Multifaceted quality improvement interventionActive-comparator control consisting of telephone-based education for patients and treatment guidelines with reminders for family physicians |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 50 years or greater
- any forearm (distal radius or ulna, "wrist") or arm (proximal humerus, "upper arm") fracture
Key exclusion criteria (5 listed)
- unable to give simple informed consent or unwilling to participate in the study
- unable to understand, read, and converse in English
- presence of pathological (e.g., cancer related) or multiple (e.g., major trauma) fractures
- already treated for osteoporosis with a bisphosphonate
- residence in a nursing home or from outside Edmonton
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 |
|---|---|---|
| case management | Other | Case Manager Intervention |
| Multifaceted quality improvement intervention | Other | Multifaceted quality improvement intervention |
Primary outcome
Proportion of untreated patients newly starting prescription osteoporosis treatment with a bisphosphonate after their fracture
Time frame: 6-months
Proportion of previously untreated patients (%) newly starting prescription osteoporosis treatment with a bisphosphonate within 6-months of an upper extremity fragility fracture
1 secondary outcome
New Treatment Persistence
Time frame: 1-year
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 24 May 2022.
- Background: PubMed 20358359Majumdar SR, Johnson JA, Bellerose D, McAlister FA, Russell AS, Hanley DA, Garg S, Lier DA, Maksymowych WP, Morrish DW, Rowe BH. Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study. Osteoporos Int. 2011 Jan;22(1):223-30. doi: 10.1007/s00198-010-1212-7. Epub 2010 Apr 1.
- Background: PubMed 18299546Majumdar SR, Johnson JA, McAlister FA, Bellerose D, Russell AS, Hanley DA, Morrish DW, Maksymowych WP, Rowe BH. Multifaceted intervention to improve diagnosis and treatment of osteoporosis in patients with recent wrist fracture: a randomized controlled trial. CMAJ. 2008 Feb 26;178(5):569-75. doi: 10.1503/cmaj.070981.
- Derived from this study: PubMed 30232538McAlister FA, Ye C, Beaupre LA, Rowe BH, Johnson JA, Bellerose D, Hassan I, Majumdar SR. Adherence to osteoporosis therapy after an upper extremity fracture: a pre-specified substudy of the C-STOP randomized controlled trial. Osteoporos Int. 2019 Jan;30(1):127-134. doi: 10.1007/s00198-018-4702-7. Epub 2018 Sep 19.
- Individual participant dataSharing planned: Undecided
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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.
Sumit R Majumdar, MD, MPH principal investigator
University of Alberta
Carrie Ye, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing case management and Multifaceted quality improvement intervention in people with Osteoporosis, run by University of Alberta 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 5 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 24 May 2022. 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 untreated patients newly starting prescription osteoporosis treatment with a bisphosphonate after their 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?
On the ClinicalTrials.gov record for NCT01401556, which also lists 3 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 24 May 2022.