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

Non-union or Delayed Healing Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01731535
• Other study ID #: 2012-0437
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2012
• Last updated: October 9, 2015
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Non-union or Delayed Healing Fractures

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with delayed healing or non-union fractures with prior bisphosphonate use	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.	01/01/2000 - 12/31/2011	Yes
Secondary	Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures.	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.	1/1/2000-12-31-2012	No