Current partner codePEPTIDESDE
NCT02239523·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

200

Locations

1

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Sep 12, 2014

  2. Study start

    Feb 21, 2017

  3. Primary completion

    Jan 17, 2019

  4. Study completion

    Feb 28, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Apr 5, 2019

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
120 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Israel. Showing up to 24 locations stored in the fast local snapshot.

Shaare Zedek Medical Center

Jerusalem, Israel

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Related PeptideStat pages

Put the record in context.

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