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

Osteoporotic Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239523
• Other study ID #: 201497CTIL
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: September 2018
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 28, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporotic Fracture
• Osteoporotic Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost benefit analysis	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.	Evaluation will be made at time of discharge and up to 4 months from the fracture event.
Primary	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.	Determination of proper treatment will be made at 4 months after the fracture.
Secondary	Percentage of patients who undergo DEXA scan.	Whether or not the patients received the medication	Evaluation will be made 4 months after the initial fracture event.