Osteoporosis, PostmenopausalNCT02157753
Quality of the Detection & Treatment of Osteoporotic Fractures in a Swiss Trauma Center
An observational study of Osteoporosis, Postmenopausal and Osteoporosis, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after about 500 fracture patients hospitalized with an age over 50 years a year. First, we were interested in the effective rate of osteoporotic fractures in this cohort. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporosis
- How many people
- 478 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2012to Dec 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: Every patient with fracture over age of 49, admitted to the Kantonsspital Aarau and treated by the traumatology department, whom a treatment for osteoporosis was suggested according to national guidelines
Who may be able to join
- age over 50 years
- any peripheral fracture, which led to hospitalisation in Kantonsspital Aarau, traumatology department
Who cannot join
- no informed consent
- age under 50 years
- not treated by traumatology department
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoporotic Fractures in a Swiss Trauma Center - Observational Study to Improve the Diagnosis and Management of and the Persistence to Therapy.
As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after about 500 fracture patients hospitalized with an age over 50 years a year. First, we were interested in the effective rate of osteoporotic fractures in this cohort. As to this objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a diagnostic pathway for every patient over 50 years of age with a fracture, including dual energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning osteoporosis and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a laboratory workup focusing on this topic. Considering all these information we sent a detailed therapy-plan to the responsible General practitioner.
The main goal of this study is to verify the persistence and compliance of the osteoporosis therapy 12-15 months after fracture and to clarify any obstacles potentially impeding therapy (prejudice, adverse events, contraindication overlooked, financial problems etc.). The investigators use a postal questionnaire provided to the patient and the general practitioner. Data collection is undertaken by a study nurse, in addition phoning for missing data by phone-call. With the aim to ameliorate the implementation of treatment, patients and general practitioners will be provided with the specifically tailored information found to be missing.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis
- Keywords
- Osteoporotic fracture, treatment for osteoporosis, adherence and compliance
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence and compliance with treatment for osteoporosis
- percentage of persons receiving prescription vs. following completely / partially treatment advice
- both, according to self declaration vs. general practitioner information
- collection of arguments if therapy was not undertaken
Measured: 12-15 month after initial fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJul 2012
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Gross, MD, Kantonsspital Aarau
- Investigators
- Thomas Gross, Prof. Dr. med., Principal investigator, Kantonsspital AarauChristoph Hemmeler, Dr.med., Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157753
- Sponsor's protocol ID
- 2013/036
- Status last verified
- Mar 2018
- First submitted
- 3 Jun 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Morell S, Hemmeler C, Amsler F, Gross T. Adherence to osteoporosis pharmacotherapy one year after osteoporotic fracture - a Swiss trauma center secondary prevention project. Swiss Med Wkly. 2017 Jul 10;147:w14451. doi: 10.4414/smw.2017.14451. eCollection 2017.
PubMed 28695555Hemmeler C, Morell S, Amsler F, Gross T. Screening for osteoporosis following non-vertebral fractures in patients aged 50 and older independently of gender or level of trauma energy-a Swiss trauma center approach. Arch Osteoporos. 2017 Dec;12(1):38. doi: 10.1007/s11657-017-0334-3. Epub 2017 Apr 8.
PubMed 28391563
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporotic Fractures in a Swiss Trauma Center - Observational Study to Improve the Diagnosis and Management of and the Persistence to Therapy.
- ClinicalTrials.gov ID
- NCT02157753
- Acronym / sponsor ID
- 2013/036
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis
- Keywords
- Osteoporotic fracture, treatment for osteoporosis, adherence and compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Jun 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.
As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after about 500 fracture patients hospitalized with an age over 50 years a year. First, we were interested in the effective rate of osteoporotic fractures in this cohort. As to this objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a diagnostic pathway for every patient over 50 years of age with a fracture, including dual energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning osteoporosis and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a laboratory workup focusing on this topic. Considering all these information we sent a detailed therapy-plan to the responsible General practitioner.
The main goal of this study is to verify the persistence and compliance of the osteoporosis therapy 12-15 months after fracture and to clarify any obstacles potentially impeding therapy (prejudice, adverse events, contraindication overlooked, financial problems etc.). The investigators use a postal questionnaire provided to the patient and the general practitioner. Data collection is undertaken by a study nurse, in addition phoning for missing data by phone-call. With the aim to ameliorate the implementation of treatment, patients and general practitioners will be provided with the specifically tailored information found to be missing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient with fracture over age of 49, admitted to the Kantonsspital Aarau and treated by the traumatology department, whom a treatment for osteoporosis was suggested according to national guidelines
Key inclusion criteria (2 listed)
- age over 50 years
- any peripheral fracture, which led to hospitalisation in Kantonsspital Aarau, traumatology department
Key exclusion criteria (3 listed)
- no informed consent
- age under 50 years
- not treated by traumatology department
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
Persistence and compliance with treatment for osteoporosis
Time frame: 12-15 month after initial fracture
* percentage of persons receiving prescription vs. following completely / partially treatment advice * both, according to self declaration vs. general practitioner information * collection of arguments if therapy was not undertaken
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 7 Mar 2018.
- Results publication: PubMed 28695555Morell S, Hemmeler C, Amsler F, Gross T. Adherence to osteoporosis pharmacotherapy one year after osteoporotic fracture - a Swiss trauma center secondary prevention project. Swiss Med Wkly. 2017 Jul 10;147:w14451. doi: 10.4414/smw.2017.14451. eCollection 2017.
- Results publication: PubMed 28391563Hemmeler C, Morell S, Amsler F, Gross T. Screening for osteoporosis following non-vertebral fractures in patients aged 50 and older independently of gender or level of trauma energy-a Swiss trauma center approach. Arch Osteoporos. 2017 Dec;12(1):38. doi: 10.1007/s11657-017-0334-3. Epub 2017 Apr 8.
Related trials for Osteoporosis, Postmenopausal
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis
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.
Thomas Gross, Prof. Dr. med. principal investigator
Kantonsspital Aarau
Christoph Hemmeler, Dr.med. principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal and Osteoporosis, run by Kantonsspital Aarau at 1 site 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 2 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Persistence and compliance with treatment for osteoporosis (time frame: 12-15 month after initial fracture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157753, which also lists 2 linked publications.
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 7 Mar 2018.