Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.

Conditions
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Osteoporotic Fracture

Intervention / Treatment
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* Procedure: Letter Group
* Procedure: Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients over age 50 with fragility fracture defined as a fall from standing or walking position Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Letter Group<br>Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician. | Procedure: Letter Group<br>* 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.<br>|
| Experimental: Intervention Group<br>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. | Procedure: Intervention Group<br>* 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.<br>* Other names: Teriparatide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Determination of proper treatment will be made at 4 months after the fracture. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who undergo DEXA scan. | Whether or not the patients received the medication | Evaluation will be made 4 months after the initial fracture event. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pathologic fracture, Insufficiency fracture, Secondary fracture, Fracture with bone fragility, Osteoporosis, Bone loss, Osteopenia, Metabolic Bone Disease, Fragility fracture