Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.

Overview

Dose and duration of bisphosphonate therapy will increase the likelihood that patients experience delayed healing of non-union fractures.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 2013

Detailed Description

We intend to review the UWHealth patient database to identify individuals with delayed or nonunion fractures. Subsequently, we will collect associated medical information related to fractures such as age of osteoporosis diagnosis, BMI, previous bisphosphonate treatment, type and location of fracture, time to complete union, other treatment needed for nonunion etc. With this information, we will evaluate the risk of delayed and nonunion fractures in patients previously receiving bisphosphonate treatment compared to a normal population. We also will investigate other potential causes of delayed or nonunion fractures in this population.

Arms, Groups and Cohorts

  • Prior bisphosphonate users
    • Patients with record of using bisphosphonate medication

Clinical Trial Outcome Measures

Primary Measures

  • The number of patients with delayed healing or non-union fractures with prior bisphosphonate use
    • Time Frame: 01/01/2000 – 12/31/2011
    • This variable will be generated by reviewing diagnosis codes from patients seen at the University of Wisconsin Hospital and Clinics during the time period identified above.

Secondary Measures

  • Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures.
    • Time Frame: 1/1/2000-12-31-2012
    • Patients with non-union or delayed healing fractures obtaining care at the University of Wisconsin Hospital or Clinics will have a medical record review conducted.

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women older than 60 years old with delayed or nonunion low trauma fracture between 01/01/2000 – 12/31/2011. Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Neil Binkley, MD, Study Director, University of Wisconsin, Madison

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