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NCT00225004 Clinical Trial

Osteoporosis and Colles Fracture

Previous or Actual Colles Fracture Clinical Trial

Official title:
Low-energy Fracture of the Wrist (Colles Fracture) and Osteoporosis. A Ten Year Follow-up and a Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00225004
Other study ID # ON-06-002-AJ
Secondary ID
Status Terminated
Phase N/A
First received September 21, 2005
Last updated April 2, 2014
Start date July 2004

Study information
Verified date April 2014
Source Northern Orthopaedic Division, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility 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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• DEXA scan
orto

Locations
Country Name City State
Denmark Northern Orthopaedic Division, Klinik Aalborg Aalborg Northern Jutland
Denmark The department of Orthopedic surgery Northern Jutland Counties, Denmark Aalborg, Jutland

Sponsors (1)
Lead Sponsor Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of Osteoporosis ten years after a Colles Fracture years No
Primary The incidence of Osteoporosis in women with an actual Colles Fracture years No