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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Shaare Zedek Medical Center

Current 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.


Original Primary Outcome: Percentage of patients with osteoporosis that are appropriately treated [ Time Frame: Determination of proper treatment will be made at 6 months after the fracture. ]

Treatment will be determined based on the Fracture Risk Assessment Tool (FRAX) score with Bone Densitometry (DEXA) score entered if performed. National Osteoporosis Foundation recommendations will be the standard against which an endocrinologist will compare recommended to actual treatment compliance.


Current Secondary Outcome: Percentage of patients who undergo DEXA scan. [ Time Frame: Evaluation will be made 4 months after the initial fracture event. ]

Whether or not the patients received the medication


Original Secondary Outcome: Percentage of patients who undergo DEXA scan. [ Time Frame: Evaluation will be made 6 months after the initial fracture event. ]

Information By: Shaare Zedek Medical Center

Dates:
Date Received: September 10, 2014
Date Started: February 21, 2017
Date Completion: January 2019
Last Updated: May 14, 2017
Last Verified: November 2016