Previous or Actual Colles FractureNCT00225004
Osteoporosis and Colles Fracture
An observational study of Previous or Actual Colles Fracture, run by Northern Orthopaedic Division, Denmark at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Previous or Actual Colles Fracture
- What is being tested?
- DEXA scan
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesDenmark
- Study dates
- Jul 2004to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: years
Who may be able to join
- Colles Fracture Women over 40 years Informed consent-
Who cannot join
- High Energy Fracture Deceases or conditions that makes the participant unable to contribute to the investigation-
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
The department of Orthopedic surgery Northern Jutland Counties, Denmark
Aalborg, Jutland, 9000
Northern Orthopaedic Division, Klinik Aalborg
Aalborg, Northern Jutland
About this study
Official title: 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.
Read the 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.
- Conditions
- Previous or Actual Colles Fracture
- Being tested
- DEXA scan
- Keywords
- Colles Fracture, Osteoporosis, BMD, Quality assurance
- Medical subject headings
- Colles' Fracture, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA scanProcedure or surgery
orto
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Osteoporosis ten years after a Colles Fracture
Measured: years
The incidence of Osteoporosis in women with an actual Colles Fracture
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJul 2004
Why it stopped: Recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previous or Actual Colles FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus K Pedersen, doctor, Principal investigator, Dept. of Orthopedic Northern Jutland Counties, DenmarkKlaus K Pedersen, doctor, Principal investigator, Department of Orthopedic surgery, Northern Jutland Counties, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225004
- Sponsor's protocol ID
- ON-06-002-AJ
- Status last verified
- Apr 2014
- First submitted
- 21 Sep 2005
- Last updated
- 3 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-energy Fracture of the Wrist (Colles Fracture) and Osteoporosis. A Ten Year Follow-up and a Prospective Study
- ClinicalTrials.gov ID
- NCT00225004
- Acronym / sponsor ID
- ON-06-002-AJ
- Conditions
- Previous or Actual Colles Fracture
- Keywords
- Colles Fracture, Osteoporosis, BMD, Quality assurance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruiting problems
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jul 2004
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- years
Key inclusion criteria (1 listed)
- Colles Fracture Women over 40 years Informed consent-
Key exclusion criteria (1 listed)
- High Energy Fracture Deceases or conditions that makes the participant unable to contribute to the investigation-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXA scanorto | Procedure or surgery | – |
Primary outcome
The incidence of Osteoporosis ten years after a Colles Fracture
Time frame: years
The incidence of Osteoporosis in women with an actual Colles Fracture
Time frame: years
Results and safety
The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus K Pedersen, doctor principal investigator
Dept. of Orthopedic Northern Jutland Counties, Denmark
Klaus K Pedersen, doctor principal investigator
Department of Orthopedic surgery, Northern Jutland Counties, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Previous or Actual Colles Fracture, run by Northern Orthopaedic Division, Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Osteoporosis ten years after a Colles Fracture (time frame: years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.