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

Withdrawn

• Conditions: Non-union or Delayed Healing Fractures

• Registration Number: NCT01731535
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-21
• Primary Completion: 2013-03
• Study Completion: 2013-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients with delayed healing or non-union fractures with prior bisphosphonate use	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 Outcome Measures

Name	Time	Method
Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures.	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.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States