- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00225004
Osteoporosis and Colles Fracture
Low-energy Fracture of the Wrist (Colles Fracture) and Osteoporosis. A Ten Year Follow-up and a Prospective Study
The primary purpose of the retrospective study is to determine the incidence of osteoporosis in women with previous Colles Fracture. Secondly, to determine to which extent Colles Fracture has led to a diagnosis and/or treatment of osteoporosis.
The primary purpose of the prospective study is to determine the incidence of osteoporosis in women with an actual Colles Fracture. Secondly, to investigate the consistency between prospective and retrospective data.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colles Fracture is known to be connected to decreased bone mineral density (BMD). Thus, it can be an early sign of osteoporosis and therefore an increased risk of new fractures.
The results of earlier studies have not been unambiguous in the respect of what extent decreased BMD in the wrist of women with Colles Fracture is synonymous of osteoporosis in the spine and the hip.
An earlier enquiry to the Danish Orthopedic Departments in 1995 showed that only 18 % of the departments diagnosed or referred patients with possible osteoporosis.
The two study designs enhance the possibilities of evaluating the relevance of Low Energy Fractures in the wrist to avoid new fractures and their relation to bone mineral density.
The results could also be a useful tool in quality assurance of the osteoporosis diagnostics.
Study Type
Contacts and Locations
Study Locations
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Jutland
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Aalborg,, Jutland, Denmark, 9000
- The department of Orthopedic surgery Northern Jutland Counties, Denmark
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Northern Jutland
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Aalborg, Northern Jutland, Denmark
- Northern Orthopaedic Division, Klinik Aalborg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Colles Fracture Women over 40 years Informed consent-
Exclusion Criteria:
High Energy Fracture Deceases or conditions that makes the participant unable to contribute to the investigation-
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of Osteoporosis ten years after a Colles Fracture
Time Frame: years
|
years
|
The incidence of Osteoporosis in women with an actual Colles Fracture
Time Frame: years
|
years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Klaus K Pedersen, doctor, Dept. of Orthopedic Northern Jutland Counties, Denmark
- Principal Investigator: Klaus K Pedersen, doctor, Department of Orthopedic surgery, Northern Jutland Counties, Denmark
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ON-06-002-AJ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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