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Trial record 74 of 414 for:    shaare zedek

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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoporotic Fracture Procedure: Letter Group Procedure: Intervention Group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Intervention
  • Dual-energy X-ray absorptiometry
  • Bone density scan
  • Bisphosphonate
  • Prolia
  • Denosumab
  • Forteo
  • Teriparatide




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   50 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Gershon Zinger, MD MS Shaare Zedek Medical Center, Jerusalem Israel

Publications:
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Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02239523     History of Changes
Other Study ID Numbers: 201497CTIL
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shaare Zedek Medical Center:
Pathologic fracture
Insufficiency fracture
Secondary fracture
Fracture with bone fragility
Osteoporosis
Bone loss
Osteopenia
Metabolic Bone Disease
Fragility fracture

Additional relevant MeSH terms:
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Fractures, Bone
Osteoporosis
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents