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

Not Applicable

Completed

• Conditions: Osteoporotic Fracture
• Interventions: Procedure: Letter Group; Procedure: Intervention Group

• Registration Number: NCT02239523
• Lead Sponsor: Shaare Zedek Medical Center

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 Timeline

• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Study Start: 2017-02-21
• Status Verified: 2018-09
• Primary Completion: 2019-01-17
• Study Completion: 2019-02-28
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letter Group	Letter Group	Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician.
Intervention Group	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with osteoporosis that are appropriately treated	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 Outcome Measures

Name	Time	Method
Percentage of patients who undergo DEXA scan.	Evaluation will be made 4 months after the initial fracture event.	Whether or not the patients received the medication

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel