Clinical trial NCT02239523: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporotic Fracture
Keywords: Pathologic fracture
Insufficiency fracture
Secondary fracture
Fracture with bone fragility
Osteoporosis
Bone loss
Osteopenia
Metabolic Bone Disease
Fragility fracture
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of patients with osteoporosis that are appropriately treated
timeFrame: Determination of proper treatment will be made at 4 months after the fracture.
Secondary outcomes:
measure: Percentage of patients who undergo DEXA scan.
timeFrame: Evaluation will be made 4 months after the initial fracture event.
Other outcomes:
measure: Cost benefit analysis
timeFrame: Evaluation will be made at time of discharge and up to 4 months from the fracture event.
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem Israel
name: Gershon Zinger, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.