Evaluation of the Risk for Radiographic and Clinical Nonunion in Patients With Previous Bisphosphonates Therapy.
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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. |
- 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.
- 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 |
|---|
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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 |
Men and women older than 60 years old with delayed or nonunion low trauma fracture beween 01/01/2000 - 12/31/2011.
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| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
| 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:
|
Fractures, Bone Wounds and Injuries Diphosphonates |
Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013