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

Primary Purpose

Osteoporotic Fracture

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Letter Group
Intervention Group
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporotic Fracture focused on measuring Pathologic fracture, Insufficiency fracture, Secondary fracture, Fracture with bone fragility, Osteoporosis, Bone loss, Osteopenia, Metabolic Bone Disease, Fragility fracture

Eligibility Criteria

50 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Letter Group

Intervention Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Percentage of patients with osteoporosis that are appropriately treated
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

Percentage of patients who undergo DEXA scan.
Whether or not the patients received the medication

Full Information

First Posted
September 10, 2014
Last Updated
April 3, 2019
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02239523
Brief Title
Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis
Official Title
Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Fracture
Keywords
Pathologic fracture, Insufficiency fracture, Secondary fracture, Fracture with bone fragility, Osteoporosis, Bone loss, Osteopenia, Metabolic Bone Disease, Fragility fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letter Group
Arm Type
Active Comparator
Arm Description
Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Letter Group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
Intervention, Dual-energy X-ray absorptiometry, Bone density scan, Bisphosphonate, Prolia, Denosumab, Forteo, Teriparatide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with osteoporosis that are appropriately treated
Description
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.
Time Frame
Determination of proper treatment will be made at 4 months after the fracture.
Secondary Outcome Measure Information:
Title
Percentage of patients who undergo DEXA scan.
Description
Whether or not the patients received the medication
Time Frame
Evaluation will be made 4 months after the initial fracture event.
Other Pre-specified Outcome Measures:
Title
Cost benefit analysis
Description
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.
Time Frame
Evaluation will be made at time of discharge and up to 4 months from the fracture event.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gershon Zinger, MD MS
Organizational Affiliation
Shaare Zedek Medical Center, Jerusalem Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
18451385
Citation
Rozental TD, Makhni EC, Day CS, Bouxsein ML. Improving evaluation and treatment for osteoporosis following distal radial fractures. A prospective randomized intervention. J Bone Joint Surg Am. 2008 May;90(5):953-61. doi: 10.2106/JBJS.G.01121.
Results Reference
background
PubMed Identifier
21915530
Citation
Edwards BJ, Koval K, Bunta AD, Genuario K, Hahr A, Andruszyn L, Williams M. Addressing secondary prevention of osteoporosis in fracture care: follow-up to "own the bone". J Bone Joint Surg Am. 2011 Aug 3;93(15):e87. doi: 10.2106/JBJS.I.00540.
Results Reference
background
PubMed Identifier
15634808
Citation
Gardner MJ, Brophy RH, Demetrakopoulos D, Koob J, Hong R, Rana A, Lin JT, Lane JM. Interventions to improve osteoporosis treatment following hip fracture. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Jan;87(1):3-7. doi: 10.2106/JBJS.D.02289.
Results Reference
background
PubMed Identifier
34180292
Citation
Zinger G, Sylvetsky N, Levy Y, Steinberg K, Bregman A, Yudkevich G, Peyser A. Early benefits of a secondary fracture prevention programme. Hip Int. 2023 Mar;33(2):332-337. doi: 10.1177/11207000211027476. Epub 2021 Jun 27.
Results Reference
derived

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

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