Postmenopausal OsteoporosisSwOFNCT02234414
Epidemiology, Identification Rate and Treatment Penetration of Osteoporotic Vertebral Fractures in Switzerland
An observational study of Postmenopausal Osteoporosis and Spinal Fractures, run by Prof. Dr. med. Kurt Lippuner at 3 sites in Switzerland.
Trial summary
In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. Read more about this study
- Who is it for?
- Ages 65 to 79 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis, Spinal Fractures
- How many people
- 303 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Feb 2009to Jun 2011
- 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 65 to 79 years
- Women only
- No healthy volunteers
- Older adult
Study population: The study population will be based on a representative (age categories, urban vs. rural, plain vs. mountain) stratified random sample taken from the general population of women living in urban/ suburban and country/ mountain regions (stratified for n = one third each, based on city code) in the german speaking part of Switzerland.
Who may be able to join
- Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
- Aged 65-79 yrs
- Written informed consent
Who cannot join
- Patients who underwent spine surgery
- Not willing or not able to sign informed consent
- In patients not willing or not able to participate, the reason for denial will be recorded for future evaluation.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Kantonsspital Olten
Olten, CH-4600
HFR Tafers
Tafers, CH-1712
Hochgebirgsklinik Davos
Wolfgang, CH-7265
About this study
Official title: Pilot Study on the Epidemiology, Identification Rate and Treatment Penetration of Vertebral Fractures Due to Osteoporosis in Switzerland (SwOF)
In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. In addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in physical activity and/ or dietary habits.
Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a combination of both would improve sensitivity and specificity is unknown.
Read more
The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients.
The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.
Read the detailed description
Examinations
- Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
- Aged 65-79 yrs
- Written informed consent
- Conditions
- Postmenopausal Osteoporosis, Spinal Fractures
- Keywords
- vertebral fracture assessment (vfa), vitamin D
- Medical subject headings
- Osteoporosis, Postmenopausal, Spinal Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years
Measured: at the only study visit
Secondary outcomes (3)
Specificity, sensitivity, positive predictive value and negative predictive value for the prediction of underlying vertebral fracture of selected risk factors, clinical signs and vitamin D level, alone or in combination
Measured: at the only study visit
Assessment of the percentage of women correctly identified with a vertebral fracture and adequately treated for underlying osteoporosis and
Measured: at the only study visit
Assessment of the differences between these women and those who are either not correctly diagnosed or not correctly treated
Measured: at the only study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startFeb 2009
- Primary completionSep 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Kurt Lippuner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Kurt Lippuner, Interessengemeinschaft Osteoporose
- Investigators
- Kurt Lippuner, Prof. Dr., Principal investigator, Interessengemeinschaft Osteoporose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234414
- Sponsor's protocol ID
- IGO-SwOF 01
- Acronym
- SwOF
- Status last verified
- Sep 2014
- First submitted
- 29 Jun 2011
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Epidemiology, Identification Rate and Treatment Penetration of Vertebral Fractures Due to Osteoporosis in Switzerland (SwOF)
- ClinicalTrials.gov ID
- NCT02234414
- Acronym / sponsor ID
- SwOF / IGO-SwOF 01
- Conditions
- Postmenopausal Osteoporosis, Spinal Fractures
- Keywords
- vertebral fracture assessment (vfa), vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Prof. Dr. med. Kurt LippunerUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Sep 2014 (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.
In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. In addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in physical activity and/ or dietary habits.
Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a combination of both would improve sensitivity and specificity is unknown.
The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients.
The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.
Detailed description
Examinations
- Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
- Aged 65-79 yrs
- Written informed consent
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will be based on a representative (age categories, urban vs. rural, plain vs. mountain) stratified random sample taken from the general population of women living in urban/ suburban and country/ mountain regions (stratified for n = one third each, based on city code) in the german speaking part of Switzerland.
Key inclusion criteria (3 listed)
- Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
- Aged 65-79 yrs
- Written informed consent
Key exclusion criteria (3 listed)
- Patients who underwent spine surgery
- Not willing or not able to sign informed consent
- In patients not willing or not able to participate, the reason for denial will be recorded for future evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years
Time frame: at the only study visit
3 secondary outcomes
Specificity, sensitivity, positive predictive value and negative predictive value for the prediction of underlying vertebral fracture of selected risk factors, clinical signs and vitamin D level, alone or in combination
Time frame: at the only study visit
Assessment of the percentage of women correctly identified with a vertebral fracture and adequately treated for underlying osteoporosis and
Time frame: at the only study visit
Assessment of the differences between these women and those who are either not correctly diagnosed or not correctly treated
Time frame: at the only study visit
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 9 Sep 2014.
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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.
Kurt Lippuner, Prof. Dr. principal investigator
Interessengemeinschaft Osteoporose
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis and Spinal Fractures, run by Prof. Dr. med. Kurt Lippuner at 3 sites in Switzerland.
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 3 inclusion and 3 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 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 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?
Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years (time frame: at the only study visit). 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 9 Sep 2014.