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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01731535

Enrollment

Registered

2012-11-21

Start date

2012-11-30

Completion date

2013-07-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-union or Delayed Healing Fractures

Keywords

osteoporosis, low trauma fracture, non-union fracture, delayed healing fracture, bisphosphonate

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.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results