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

Management Strategies by an Orthopedic Department to Improve the Evaluation and Treatment of Osteoporosis.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02239523
Enrollment
200
Registered
2014-09-12
Start date
2017-02-21
Completion date
2019-02-28
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic Fracture

Keywords

Pathologic fracture, Insufficiency fracture, Secondary fracture, Fracture with bone fragility, Osteoporosis, Bone loss, Osteopenia, Metabolic Bone Disease, Fragility fracture

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.

Interventions

PROCEDURELetter 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.

PROCEDUREIntervention 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.

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 120 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients with osteoporosis that are appropriately treatedDetermination 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

MeasureTime frameDescription
Percentage of patients who undergo DEXA scan.Evaluation will be made 4 months after the initial fracture event.Whether or not the patients received the medication

Other

MeasureTime frameDescription
Cost benefit analysisEvaluation 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026