Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis
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|ClinicalTrials.gov Identifier: NCT02239523|
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoporotic Fracture||Procedure: Letter Group Procedure: Intervention Group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.|
|Actual Study Start Date :||February 21, 2017|
|Actual Primary Completion Date :||January 17, 2019|
|Actual Study Completion Date :||February 28, 2019|
Active Comparator: Letter Group
Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician.
Procedure: Letter Group
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.
Experimental: 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.
Procedure: Intervention Group
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.
- 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.
- 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
- Cost benefit analysis [ Time Frame: Evaluation will be made at time of discharge and up to 4 months from the fracture event. ]Cost analysis will be made for each patient during the hospitalization and for 3 months after the fracture to capture complications related to the initial event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239523
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Principal Investigator:||Gershon Zinger, MD MS||Shaare Zedek Medical Center, Jerusalem Israel|