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

NCT ID: NCT02239523

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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Osteoporotic Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Letter Group

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

Group Type ACTIVE_COMPARATOR

Letter Group

Intervention Type PROCEDURE

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 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.

Group Type EXPERIMENTAL

Intervention Group

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Intervention Dual-energy X-ray absorptiometry Bone density scan Bisphosphonate Prolia Denosumab Forteo Teriparatide

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gershon Zinger, MD MS

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem Israel

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 18451385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21915530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15634808 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34180292 (View on PubMed)

Other Identifiers

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201497CTIL

Identifier Type: -

Identifier Source: org_study_id

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