Osteoporotic FractureNCT02239523
Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis
A study testing Letter Group and Intervention Group in people with Osteoporotic Fracture, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Read more about this study
- Who is it for?
- Ages 50 to 120 years
- Conditions the study is for
- Osteoporotic Fracture
- What is being tested?
- Letter Group and Intervention Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Feb 2017to 28 Feb 2019
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over age 50 with fragility fracture defined as a fall from standing or walking position
Who cannot join
- Patients with metastatic cancer
- Known metabolic bone disease
- End-of-life care
- Inability to provide consent
- Known MRSA carriers
- Fractures of the trochanter alone, shaft or peri-prosthetic fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.
Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Studies have consistently shown that the recommendations of the International Osteoporosis Foundation and World Health Organization are not being followed. Orthopedics treats the patients for their fractures and primary care physicians focus on general health but no one is taking responsibility for bone health. Strategies to convince primary care to assume care have not succeeded. On the other hand, strategies where orthopedics takes some responsibility have shown success. This prospective 2-arm study will evaluate the success of effort by an academic orthopedic department in osteoporosis evaluation and treatment. We hypothesize that with greater effort by the orthopedic department, the better the adherence to standards of care. A cost benefit analysis will be made in parallel.
Read the detailed description
Patients who present to the orthopedic department in a level I trauma center will be prospectively randomized into one of two groups:
Letter Group: At time of discharge, patients will be sent home with a discharge letter that includes standard recommendations for evaluation and treatment. They will be asked to give the letter to their primary care physician.
Intervention Group: There will be 4 interventions. The patient will be given a short pamphlet with explaining osteoporosis and the importance of treatment. The orthopedic department will perform a bone density testing (DEXA). They will be given a letter with a specific medication recommendation based on a protocol determined by our endocrinology department. They will be asked to give both DEXA and medication recommendation to their primary care doctor to initiate treatment. Finally, a research assistant will contact the patient monthly to encourage them to start treatment.
- Conditions
- Osteoporotic Fracture
- Being tested
- Letter Group, Intervention Group
- Keywords
- Pathologic fracture, Insufficiency fracture, Secondary fracture, Fracture with bone fragility, Osteoporosis, Bone loss, Osteopenia, Metabolic Bone Disease, Fragility fracture
- Medical subject headings
- Osteoporotic Fractures, Fractures, Spontaneous, Fractures, Stress, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter GroupProcedure or surgery
At time of discharge from the hospital, patients will be sent home with a letter that includes standard recommendations for evaluation and treatment for osteoporosis. This will be asked to give the letter to their primary care physician.
Intervention GroupProcedure or surgery
Also called Intervention, Dual-energy X-ray absorptiometry, Bone density scan, Bisphosphonate
The orthopedic department will be responsible for arranging bone density testing (DEXA) and recommending specific medication after discharge. A research assistant will call monthly to encourage treatment.
| Study group | Role | What they receive |
|---|---|---|
| Letter Group | Active comparator | Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician. Receives: Procedure: Letter Group |
| Intervention Group | Experimental | Patients will be given a pamphlet about osteoporosis and importance of treatment, have a bone density test (DEXA) arranged, be given a specific medication recommendation and monthly followup phone calls. Receives: Procedure: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with osteoporosis that are appropriately treated
Treatment will be determined based on a pre-determined algorithm by our endocrinology department. This will be based on patient factors and results of DEXA is not part of the algorithm. All patients with a fragility fracture of the hip, regardless of DEXA results will be considered for treatment.
Measured: Determination of proper treatment will be made at 4 months after the fracture.
Secondary outcomes (1)
Percentage of patients who undergo DEXA scan.
Whether or not the patients received the medication
Measured: Evaluation will be made 4 months after the initial fracture event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start21 Feb 2017
- Primary completion17 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic FractureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gershon Zinger, MD MS, Principal investigator, Shaare Zedek Medical Center, Jerusalem Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239523
- Sponsor's protocol ID
- 201497CTIL
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2014
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rozental TD, Makhni EC, Day CS, Bouxsein ML. Improving evaluation and treatment for osteoporosis following distal radial fractures. A prospective randomized intervention. J Bone Joint Surg Am. 2008 May;90(5):953-61. doi: 10.2106/JBJS.G.01121.
PubMed 18451385Edwards BJ, Koval K, Bunta AD, Genuario K, Hahr A, Andruszyn L, Williams M. Addressing secondary prevention of osteoporosis in fracture care: follow-up to "own the bone". J Bone Joint Surg Am. 2011 Aug 3;93(15):e87. doi: 10.2106/JBJS.I.00540.
PubMed 21915530Gardner MJ, Brophy RH, Demetrakopoulos D, Koob J, Hong R, Rana A, Lin JT, Lane JM. Interventions to improve osteoporosis treatment following hip fracture. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Jan;87(1):3-7. doi: 10.2106/JBJS.D.02289.
PubMed 15634808Zinger G, Sylvetsky N, Levy Y, Steinberg K, Bregman A, Yudkevich G, Peyser A. Early benefits of a secondary fracture prevention programme. Hip Int. 2023 Mar;33(2):332-337. doi: 10.1177/11207000211027476. Epub 2021 Jun 27.
PubMed 34180292
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.
- ClinicalTrials.gov ID
- NCT02239523
- Acronym / sponsor ID
- 201497CTIL
- Conditions
- Osteoporotic Fracture
- Keywords
- Pathologic fracture, Insufficiency fracture, Secondary fracture, Fracture with bone fragility, Osteoporosis, Bone loss, Osteopenia, Metabolic Bone Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 12 Sep 2014 (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 who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Studies have consistently shown that the recommendations of the International Osteoporosis Foundation and World Health Organization are not being followed. Orthopedics treats the patients for their fractures and primary care physicians focus on general health but no one is taking responsibility for bone health. Strategies to convince primary care to assume care have not succeeded. On the other hand, strategies where orthopedics takes some responsibility have shown success. This prospective 2-arm study will evaluate the success of effort by an academic orthopedic department in osteoporosis evaluation and treatment. We hypothesize that with greater effort by the orthopedic department, the better the adherence to standards of care. A cost benefit analysis will be made in parallel.
Detailed description
Patients who present to the orthopedic department in a level I trauma center will be prospectively randomized into one of two groups:
Letter Group: At time of discharge, patients will be sent home with a discharge letter that includes standard recommendations for evaluation and treatment. They will be asked to give the letter to their primary care physician.
Intervention Group: There will be 4 interventions. The patient will be given a short pamphlet with explaining osteoporosis and the importance of treatment. The orthopedic department will perform a bone density testing (DEXA). They will be given a letter with a specific medication recommendation based on a protocol determined by our endocrinology department. They will be asked to give both DEXA and medication recommendation to their primary care doctor to initiate treatment. Finally, a research assistant will contact the patient monthly to encourage them to start treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letter Group | Active comparator | Procedure: Letter GroupPatients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician. |
| Intervention Group | Experimental | Procedure: Intervention GroupPatients will be given a pamphlet about osteoporosis and importance of treatment, have a bone density test (DEXA) arranged, be given a specific medication recommendation and monthly followup phone calls. |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over age 50 with fragility fracture defined as a fall from standing or walking position
Key exclusion criteria (6 listed)
- Patients with metastatic cancer
- Known metabolic bone disease
- End-of-life care
- Inability to provide consent
- Known MRSA carriers
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 |
|---|---|---|
| Letter GroupAt time of discharge from the hospital, patients will be sent home with a letter that includes standard recommendations for evaluation and treatment for osteoporosis. This will be asked to give the letter to their primary care physician. | Procedure or surgery | Letter Group |
| Intervention GroupAlso: Intervention, Dual-energy X-ray absorptiometry, Bone density scan, BisphosphonateThe orthopedic department will be responsible for arranging bone density testing (DEXA) and recommending specific medication after discharge. A research assistant will call monthly to encourage treatment. | Procedure or surgery | Intervention Group |
Primary outcome
Percentage of patients with osteoporosis that are appropriately treated
Time frame: Determination of proper treatment will be made at 4 months after the fracture.
Treatment will be determined based on a pre-determined algorithm by our endocrinology department. This will be based on patient factors and results of DEXA is not part of the algorithm. All patients with a fragility fracture of the hip, regardless of DEXA results will be considered for treatment.
1 secondary outcome
Percentage of patients who undergo DEXA scan.
Time frame: Evaluation will be made 4 months after the initial fracture event.
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 5 Apr 2019.
- Background: PubMed 18451385Rozental TD, Makhni EC, Day CS, Bouxsein ML. Improving evaluation and treatment for osteoporosis following distal radial fractures. A prospective randomized intervention. J Bone Joint Surg Am. 2008 May;90(5):953-61. doi: 10.2106/JBJS.G.01121.
- Background: PubMed 21915530Edwards BJ, Koval K, Bunta AD, Genuario K, Hahr A, Andruszyn L, Williams M. Addressing secondary prevention of osteoporosis in fracture care: follow-up to "own the bone". J Bone Joint Surg Am. 2011 Aug 3;93(15):e87. doi: 10.2106/JBJS.I.00540.
- Background: PubMed 15634808Gardner MJ, Brophy RH, Demetrakopoulos D, Koob J, Hong R, Rana A, Lin JT, Lane JM. Interventions to improve osteoporosis treatment following hip fracture. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Jan;87(1):3-7. doi: 10.2106/JBJS.D.02289.
- Derived from this study: PubMed 34180292Zinger G, Sylvetsky N, Levy Y, Steinberg K, Bregman A, Yudkevich G, Peyser A. Early benefits of a secondary fracture prevention programme. Hip Int. 2023 Mar;33(2):332-337. doi: 10.1177/11207000211027476. Epub 2021 Jun 27.
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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.
Gershon Zinger, MD MS principal investigator
Shaare Zedek Medical Center, Jerusalem Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter Group and Intervention Group in people with Osteoporotic Fracture, run by Shaare Zedek Medical Center at 1 site in Israel.
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 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 5 Apr 2019. 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 Israel. 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?
Percentage of patients with osteoporosis that are appropriately treated (time frame: Determination of proper treatment will be made at 4 months after the 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 NCT02239523, which also lists 4 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 5 Apr 2019.