Osteoporotic FracturesNCT02403726
Osteoporosis Associated Vertebral Fractures - Medical and Socio-economic Aspects in Austria
An observational study of Osteoporotic Fractures, run by Medical University of Vienna.
Trial summary
The purposes of this study were to analyse demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Fractures
- What is being tested?
- Operation and Non-operative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 694 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Mar 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was a retrospective case series of 694 patients, in which the fracture was caused due to primary or secondary osteoporosis, and who were treated at the department of trauma surgery at our level-I trauma center.
Who may be able to join
- -patients older than 50 years of age with vertebral fractures at the thoracic or lumbar spine caused by a low-energy trauma or without any trauma, or with vertebral fractures at the thoracic or lumbar spine with typical osteoporotic deformity of the vertebrae (wedge, fish, or flat)
Who cannot join
- patients younger than 50 years of age
- vertebral fractures at the cervical spine
- vertebral fractures at the thoracic or lumbar spine caused by a high-energy trauma (motor-vehicle accident, sports-related accident, fall from a considerable height)
- patients suffering from a malignancy, making a pathological fracture presumably, patients with vertebral fractures, whose dataset of follow-up monitoring was lacking, to make an evaluation of osteoporotic involvement impossible
About this study
The purposes of this study were to analyse demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures.
- Conditions
- Osteoporotic Fractures
- Being tested
- Operation, Non-operative treatment
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OperationProcedure or surgery
Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with operation.
Non-operative treatmentProcedure or surgery
Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with non-operative treatment.
| Study group | Role | What they receive |
|---|---|---|
| osteoporosis associated vertebral fractures | Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures. Receives: Procedure: Operation; Procedure: Non-operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
demographic aspects
demographic aspects (age, social status) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment
Measured: at least two year follow up
gender aspects
gender aspects (sex) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment
Measured: at least two year follow up
socio economic aspects
socio-economic aspects (cost ratio) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment
Measured: at least two year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJan 2011
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Enrolment
- 694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403726
- Sponsor's protocol ID
- 2011/896
- Status last verified
- Mar 2015
- First submitted
- 20 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Associated Vertebral Fractures - Medical and Socio-economic Aspects in Austria
- ClinicalTrials.gov ID
- NCT02403726
- Acronym / sponsor ID
- 2011/896
- Conditions
- Osteoporotic Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 694 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- First posted
- 31 Mar 2015 (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 purposes of this study were to analyse demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporosis associated vertebral fractures | – | Procedure: Operation, Procedure: Non-operative treatmentAnalyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was a retrospective case series of 694 patients, in which the fracture was caused due to primary or secondary osteoporosis, and who were treated at the department of trauma surgery at our level-I trauma center.
Key inclusion criteria (1 listed)
- -patients older than 50 years of age with vertebral fractures at the thoracic or lumbar spine caused by a low-energy trauma or without any trauma, or with vertebral fractures at the thoracic or lumbar spine with typical osteoporotic deformity of the vertebrae (wedge, fish, or flat)
Key exclusion criteria (4 listed)
- patients younger than 50 years of age
- vertebral fractures at the cervical spine
- vertebral fractures at the thoracic or lumbar spine caused by a high-energy trauma (motor-vehicle accident, sports-related accident, fall from a considerable height)
- patients suffering from a malignancy, making a pathological fracture presumably, patients with vertebral fractures, whose dataset of follow-up monitoring was lacking, to make an evaluation of osteoporotic involvement impossible
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 |
|---|---|---|
| OperationAnalyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with operation. | Procedure or surgery | osteoporosis associated vertebral fractures |
| Non-operative treatmentAnalyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with non-operative treatment. | Procedure or surgery | osteoporosis associated vertebral fractures |
Primary outcome
demographic aspects
Time frame: at least two year follow up
demographic aspects (age, social status) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment
gender aspects
Time frame: at least two year follow up
gender aspects (sex) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment
socio economic aspects
Time frame: at least two year follow up
socio-economic aspects (cost ratio) of osteoporosis associated vertebral fractures treated with either operation or non operative treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporotic Fractures, run by Medical University of Vienna.
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 4 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: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
demographic aspects (time frame: at least two year follow up). The study lists 3 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 31 Mar 2015.