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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Neil Binkley, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01731535
First received: November 14, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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


Condition
Non-union or Delayed Healing Fractures

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The number of patients with delayed healing or non-union fractures with prior bisphosphonate use [ Time Frame: 01/01/2000 - 12/31/2011 ] [ Designated as safety issue: Yes ]
    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:
  • Evaluation of patient variables (demographic or medical history) related to non-union or delayed healing fractures. [ Time Frame: 1/1/2000-12-31-2012 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 635
Study Start Date: November 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prior bisphosphonate users
Patients with record of using bisphosphonate medication

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men and women older than 60 years old with delayed or nonunion low trauma fracture beween 01/01/2000 - 12/31/2011.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731535

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Director: Neil Binkley, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Neil Binkley, Professor of Medicine, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01731535     History of Changes
Other Study ID Numbers: 2012-0437
Study First Received: November 14, 2012
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
osteoporosis, low trauma fracture, non-union fracture, delayed healing fracture, bisphosphonate

Additional relevant MeSH terms:
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014