Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shaare Zedek Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Percentage of patients with osteoporosis that are appropriately treated
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Letter Group
Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician.
Intervention: Letter Group (Procedure)
Intervention Group
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.
Intervention: Intervention Group (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of patients who undergo DEXA scan.(Evaluation will be made 4 months after the initial fracture event.)
