OsteoporosisNCT00175175
Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
A study testing Allied health professional-run osteoporosis service ("case-management") in people with Osteoporosis and Hip Fracture, run by University of Alberta at 1 site in Canada.
Trial summary
Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Hip Fracture
- What is being tested?
- Allied health professional-run osteoporosis service ("case-management")
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2002to not given
- 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
- hip fracture patient > 50 years of age
- able to give consent (or proxy consent available)
- lives within health region
- no contraindications to bisphosphonate therapy
Who cannot join
- refuses to participate or consent
- dementia or delirium without a proxy consent available
- nursing home or longterm care
- pathologic fracture
- chronic glucocorticoid use
- already receiving prescription osteoporosis treatment (calcium and vitamin D do not preclude inclusion)
Trial locations and contacts
1 site in 1 country.
About this study
Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.
We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.
Read the detailed description
Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.
We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.
- Conditions
- Osteoporosis, Hip Fracture
- Being tested
- Allied health professional-run osteoporosis service ("case-management")
- Keywords
- osteoporosis treatment, osteoporosis testing, hip fracture, quality improvement
- Medical subject headings
- Osteoporosis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allied health professional-run osteoporosis service ("case-management")Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
Secondary outcomes (5)
Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
Proportion in receipt of a BMD test at 6 months and 12 months
Proportion still adherent to osteoporosis treatments at 6 months and 12 months
Proportion of patients with recurrent fractures at 6 months and 12 months
Cost effectiveness analyses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2002
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.
- More trials run by University of AlbertaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Royal Alexandra Hospital
- Investigators
- Sumit R Majumdar, MD, MPH, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175175
- Sponsor's protocol ID
- AHFMR #200100791
- Status last verified
- Sep 2006
- First submitted
- 9 Sep 2005
- Last updated
- 15 Sep 2006
- Results posted
- No
Publications
Morrish DW, Beaupre LA, Bell NR, Cinats JG, Hanley DA, Harley CH, Juby AG, Lier DA, Maksymowych WP, Majumdar SR. Facilitated bone mineral density testing versus hospital-based case management to improve osteoporosis treatment for hip fracture patients: additional results from a randomized trial. Arthritis Rheum. 2009 Feb 15;61(2):209-15. doi: 10.1002/art.24097.
PubMed 19177538Majumdar SR, Lier DA, Beaupre LA, Hanley DA, Maksymowych WP, Juby AG, Bell NR, Morrish DW. Osteoporosis case manager for patients with hip fractures: results of a cost-effectiveness analysis conducted alongside a randomized trial. Arch Intern Med. 2009 Jan 12;169(1):25-31. doi: 10.1001/archinte.169.1.25.
PubMed 19139320Majumdar SR, Beaupre LA, Harley CH, Hanley DA, Lier DA, Juby AG, Maksymowych WP, Cinats JG, Bell NR, Morrish DW. Use of a case manager to improve osteoporosis treatment after hip fracture: results of a randomized controlled trial. Arch Intern Med. 2007 Oct 22;167(19):2110-5. doi: 10.1001/archinte.167.19.2110.
PubMed 17954806
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT00175175
- Acronym / sponsor ID
- AHFMR #200100791
- Conditions
- Osteoporosis, Hip Fracture
- Keywords
- osteoporosis treatment, osteoporosis testing, hip fracture, quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, Royal Alexandra Hospital
- Study start
- Mar 2002
- First posted
- 15 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.
Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.
We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.
Detailed description
Patients with hip fractures have suffered the most devastating consequence of osteoporosis; and yet, they are rarely if ever tested or treated for the condition, even though they remain at high risk of recurrent fracture.
We hypothesize that, compared with usual care, an allied health professional-run osteoporosis service (case management) will be able to increase testing and treatment of osteoporosis in patients at high risk of fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hip fracture patient > 50 years of age
- able to give consent (or proxy consent available)
- lives within health region
- no contraindications to bisphosphonate therapy
Key exclusion criteria (6 listed)
- refuses to participate or consent
- dementia or delirium without a proxy consent available
- nursing home or longterm care
- pathologic fracture
- chronic glucocorticoid use
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 |
|---|---|---|
| Allied health professional-run osteoporosis service ("case-management") | Behavioural | – |
Primary outcome
The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture
5 secondary outcomes
Proportion of patients taking prescription osteoporosis treatment at 6 months and 12 months
Proportion in receipt of a BMD test at 6 months and 12 months
Proportion still adherent to osteoporosis treatments at 6 months and 12 months
Proportion of patients with recurrent fractures at 6 months and 12 months
Cost effectiveness analyses
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 15 Sep 2006.
- Derived from this study: PubMed 19177538Morrish DW, Beaupre LA, Bell NR, Cinats JG, Hanley DA, Harley CH, Juby AG, Lier DA, Maksymowych WP, Majumdar SR. Facilitated bone mineral density testing versus hospital-based case management to improve osteoporosis treatment for hip fracture patients: additional results from a randomized trial. Arthritis Rheum. 2009 Feb 15;61(2):209-15. doi: 10.1002/art.24097.
- Derived from this study: PubMed 19139320Majumdar SR, Lier DA, Beaupre LA, Hanley DA, Maksymowych WP, Juby AG, Bell NR, Morrish DW. Osteoporosis case manager for patients with hip fractures: results of a cost-effectiveness analysis conducted alongside a randomized trial. Arch Intern Med. 2009 Jan 12;169(1):25-31. doi: 10.1001/archinte.169.1.25.
- Derived from this study: PubMed 17954806Majumdar SR, Beaupre LA, Harley CH, Hanley DA, Lier DA, Juby AG, Maksymowych WP, Cinats JG, Bell NR, Morrish DW. Use of a case manager to improve osteoporosis treatment after hip fracture: results of a randomized controlled trial. Arch Intern Med. 2007 Oct 22;167(19):2110-5. doi: 10.1001/archinte.167.19.2110.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allied health professional-run osteoporosis service ("case-management") in people with Osteoporosis and Hip Fracture, 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 4 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: finished, as of the sponsor's last update on 15 Sep 2006. 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?
The proportion of patients taking bisphosphonate therapy within 6 months of hip fracture. 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 NCT00175175, 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 15 Sep 2006.