Hip FracturesPhase 2/3NCT00280943
Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities
A Phase 2/3 study testing Long-term care facilities in the intervention arm will receive education and feedback audit on performance in people with Hip Fractures and Osteoporosis, run by Duke University at 1 site in United States.
Trial summary
Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures, Osteoporosis
- What is being tested?
- Long-term care facilities in the intervention arm will receive education and feedback audit on performance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2007
- Phase
- Phase 2/3
- 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
- Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities Written for FDA Approved Medications for Osteoporosis Treatment.
Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. This trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for FDA approved medications for osteoporosis treatment.
- Conditions
- Hip Fractures, Osteoporosis
- Being tested
- Long-term care facilities in the intervention arm will receive education and feedback audit on performance
- Keywords
- All NC LTC facilities having ten residents with a hip fracture or osteoporosis on the MDS will be invited to participate in the trial
- Medical subject headings
- Hip Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term care facilities in the intervention arm will receive education and feedback audit on performanceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new prescriptions for FDA-Approved osteoporosis medications.
Secondary outcomes (1)
Secondary Outcome Measures: Changes in number of bone mineral density test ordered, change in the number of hip protectors issued, change in the number of prescriptions for calcium and vitamin D, changes in the rate of new osteoporotic fractures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startJan 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth W Lyles, M.D., Principal investigator, Duke UniversityCathleen S. Colon-Emeric, MD, MHSc, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280943
- Sponsor's protocol ID
- 4686-05-7R2ER
- Status last verified
- Oct 2007
- First submitted
- 20 Jan 2006
- Last updated
- 26 Oct 2023
- Results posted
- No
Publications
Colon-Emeric CS, Lyles KW, House P, Levine DA, Schenck AP, Allison J, Gorospe J, Fermazin M, Oliver K, Curtis JR, Weissman N, Xie A, Saag KG. Randomized trial to improve fracture prevention in nursing home residents. Am J Med. 2007 Oct;120(10):886-92. doi: 10.1016/j.amjmed.2007.04.020.
PubMed 17904460
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities Written for FDA Approved Medications for Osteoporosis Treatment.
- ClinicalTrials.gov ID
- NCT00280943
- Acronym / sponsor ID
- 4686-05-7R2ER
- Conditions
- Hip Fractures, Osteoporosis
- Keywords
- All NC LTC facilities having ten residents with a hip fracture or osteoporosis on the MDS will be invited to participate in the trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 24 Jan 2006 (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.
Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. This trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for FDA approved medications for osteoporosis treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 (1 listed)
- Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Long-term care facilities in the intervention arm will receive education and feedback audit on performance | Behavioural | – |
Primary outcome
Number of new prescriptions for FDA-Approved osteoporosis medications.
1 secondary outcome
Secondary Outcome Measures: Changes in number of bone mineral density test ordered, change in the number of hip protectors issued, change in the number of prescriptions for calcium and vitamin D, changes in the rate of new osteoporotic fractures.
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 26 Oct 2023.
- Results publication: PubMed 17904460Colon-Emeric CS, Lyles KW, House P, Levine DA, Schenck AP, Allison J, Gorospe J, Fermazin M, Oliver K, Curtis JR, Weissman N, Xie A, Saag KG. Randomized trial to improve fracture prevention in nursing home residents. Am J Med. 2007 Oct;120(10):886-92. doi: 10.1016/j.amjmed.2007.04.020.
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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.
Kenneth W Lyles, M.D. principal investigator
Duke University
Cathleen S. Colon-Emeric, MD, MHSc principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Long-term care facilities in the intervention arm will receive education and feedback audit on performance in people with Hip Fractures and Osteoporosis, run by Duke University at 1 site in United States.
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 0 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 26 Oct 2023. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of new prescriptions for FDA-Approved osteoporosis medications.. 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 NCT00280943, which also lists 1 linked publication.
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 26 Oct 2023.