OsteoporosisNCT02220699
Screening for Osteoporosis in General Practice
An observational study of Osteoporosis, run by Aalborg University at 1 site in Denmark.
Trial summary
All Danish general practices have a data capture system that collects selected data from the electronic patient record. These data are used for various quality assurance purposes. The aim of the study is to evaluate the quality assurance system/program that identifies patients having an increased risk of osteoporosis. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 367 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to May 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at list at the participating general pracitices who are identified to be at an increased risk of osteoporosis by the data capture program are invited to participate (by direct contact, mail or e-mail)
Who may be able to join
- Patient identified as being at an increased risk of osteoporosis by the data capture system
Who cannot join
- Known osteoporosis.
- Patients treated with alendronate.
- Patients below 25 years of age.
- Bone metastasis.
- Terminal disease.
- Severe dementia or other disease or condition that is incompatible with participation.
Show all 9Show fewer
- Bone mineral density scan within the past 3 years.
- Errors in their ICPC coding that leads to the patient being misclassified as having an increased risk of osteoporosis.
- Patients not wanting to participate.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Lægerne Sløjfen (a family medicine clinic)
Aalborg, North Denmark, 9220
About this study
Official title: Screening for Osteoporosis in General Practice. Identifying Patients With Osteoporosis in General Practice by Using the Program Data Capture
All Danish general practices have a data capture system that collects selected data from the electronic patient record. These data are used for various quality assurance purposes. The aim of the study is to evaluate the quality assurance system/program that identifies patients having an increased risk of osteoporosis.
Read the detailed description
Background/Method
General practitioners (GPs) have the Sentinel data capture program as an integrated part of their medical record system. The program identifies if a patient has one or more of the following risk factors registered with an ICPC code (International Classification of Primary Care - 2, Wonca International Classification Committee (WICC)):
Alcohol abuse (P15), chronic obstructive pulmonary disease (COPD) (R95), hyperthyroidism (T85), rheumatoid arthritis (L88), fracture (L72, L73, L74, L75 and L76 (age > 50))*, anorexia (P86), glomerulonephritis/ nephropathy (U88), early menopause (ages 40 to 45 and X05), smoker (current/former P17), corticosteroid treatment (at least two prescriptions), body mass index (BMI) (between 10-19).
*L72: radius/ulna fracture, L73: tibia/fibula fracture, L74: hand/foot fracture, L75: femur fracture, L76: NEC (not elsewhere classified) fracture.
The GP can generate a list of his own patients that have an increased risk of osteoporosis with name, personal identification number, age, address, eGFR (estimated glomerular filtration rate), BMI, an indication of which of the above mentioned diagnoses the patient has, and whether the patient had been instructed in calcium and vitamin D intake. In order to generate a list, the GP must have been using ICPC coding for at least 6 months with a minimum of 70% of patient contacts.
The GP can afterwards invite these high-risk individuals for a consultation focussing on osteoporosis prevention.
The Study
The study has initiated in January 2014 including two general practices (Clinic A \& B) from the Aalborg Municipality that volunteered to participate. Based on the investigators pilot study the investigators aimed at clinics with approximately 200 patients at risk in each.
Clinic A (www.laegernesloejfen.dk) is located in eastern Aalborg, Denmark. Clinic B (www.lægerneiskalborg.dk) is located in southwest Aalborg, Denmark.
Clinic A and B's lists of patients at an increased risk of osteoporosis is printed and downloaded, along with their ICPC coded diagnoses and data.
The patients' medical records are screened for exclusion criteria. Eligible patients are contacted and asked to come for a consultation regarding the risk of developing osteoporosis. The patients are contacted directly if they visit the clinic anyway; otherwise they are contacted by e-mail or letter.
Patients coming for a consultation are given a questionnaire regarding osteoporosis risk factors in relation to lifestyle, diet, diseases predisposing osteoporosis, fall prophylaxis, and medication. The questionnaire also evaluate the patient's attitude towards being offered preventive examination and treatment by his/hers general practitioner. Patients wanting a consultation, but not wishing to participate in the scientific study are examined and offered treatment equal to the consenting patient according to national standards.
The patients then have a consultation regarding osteoporosis prevention (typically by a nurse). During the consultation the patient's different risk factors are discussed and advice is given regarding fall prophylaxis, diet, calcium and vitamin D. The patient's medication is examined as specified by national guidelines. All patients are then offered referral to a DXA-scan.
Patients that are scanned and classified as having osteoporosis are offered a new consultation regarding osteoporosis treatment and blood tests for secondary osteoporosis screening purposes.
Patients with osteopenia and normal bone mineral density are informed about their test result and if necessary advised to have a new DXA-scan in a few years.
The study is based on the routine identification of patients at risk of osteoporosis found by using the Sentinel data capture program. Intervention is not used in the study, however the patients at risk are offered regular preventive examination according to their risk (DXA-scan). The study analyses data based on the quality assurance work regarding osteoporosis of the general practices.
Patients are informed that participation is completely voluntary and they can withdraw from the study at any time and it will have no bearing on present or future treatment. All participating patients give oral and written informed consent.
Patients not wanting to participate will not be part of the study and only their sex, age, risk factors and reason for exclusion will be registered anonymously in order to evaluate the selection of patients.
Lack of participation in the study will have no consequences on the examination and treatment offered to patients at risk.
- Conditions
- Osteoporosis
- Keywords
- Ostoporosis, Primary Prevention, Health Promotion, General Practice, Secondary screening, Patients at increased risk of osteoporosis
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with osteoporosis
Participating patients are referred to a bone mineral density measurement (DXA scan). The exact time depends on the waiting time for bone mineral density Measurements.
Measured: 6 weeks after visit at the GP clinic
Secondary outcomes (2)
Number of patients with osteopenia
At the time of bone mineral density measurement
Measured: 6 weeks after visit at the GP clinic
Cost of identifying a patient with osteoporosis
The total cost from inviting the patients until the patients have finished all examinations, except blood testing for secondary osteoporosis (but not including expenses after treatment for osteoporosis may have begun)
Measured: 2 weeks after bone mineral density measurment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Martin Bach Jensen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220699
- Sponsor's protocol ID
- FEA-RN-2014-1
- Status last verified
- Jul 2016
- First submitted
- 17 Aug 2014
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Osteoporosis in General Practice. Identifying Patients With Osteoporosis in General Practice by Using the Program Data Capture
- ClinicalTrials.gov ID
- NCT02220699
- Acronym / sponsor ID
- FEA-RN-2014-1
- Conditions
- Osteoporosis
- Keywords
- Ostoporosis, Primary Prevention, Health Promotion, General Practice, Secondary screening, Patients at increased risk of osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Aug 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.
All Danish general practices have a data capture system that collects selected data from the electronic patient record. These data are used for various quality assurance purposes. The aim of the study is to evaluate the quality assurance system/program that identifies patients having an increased risk of osteoporosis.
Detailed description
Background/Method
General practitioners (GPs) have the Sentinel data capture program as an integrated part of their medical record system. The program identifies if a patient has one or more of the following risk factors registered with an ICPC code (International Classification of Primary Care - 2, Wonca International Classification Committee (WICC)):
Alcohol abuse (P15), chronic obstructive pulmonary disease (COPD) (R95), hyperthyroidism (T85), rheumatoid arthritis (L88), fracture (L72, L73, L74, L75 and L76 (age > 50))*, anorexia (P86), glomerulonephritis/ nephropathy (U88), early menopause (ages 40 to 45 and X05), smoker (current/former P17), corticosteroid treatment (at least two prescriptions), body mass index (BMI) (between 10-19).
*L72: radius/ulna fracture, L73: tibia/fibula fracture, L74: hand/foot fracture, L75: femur fracture, L76: NEC (not elsewhere classified) fracture.
The GP can generate a list of his own patients that have an increased risk of osteoporosis with name, personal identification number, age, address, eGFR (estimated glomerular filtration rate), BMI, an indication of which of the above mentioned diagnoses the patient has, and whether the patient had been instructed in calcium and vitamin D intake. In order to generate a list, the GP must have been using ICPC coding for at least 6 months with a minimum of 70% of patient contacts.
The GP can afterwards invite these high-risk individuals for a consultation focussing on osteoporosis prevention.
The Study
The study has initiated in January 2014 including two general practices (Clinic A \& B) from the Aalborg Municipality that volunteered to participate. Based on the investigators pilot study the investigators aimed at clinics with approximately 200 patients at risk in each.
Clinic A (www.laegernesloejfen.dk) is located in eastern Aalborg, Denmark. Clinic B (www.lægerneiskalborg.dk) is located in southwest Aalborg, Denmark.
Clinic A and B's lists of patients at an increased risk of osteoporosis is printed and downloaded, along with their ICPC coded diagnoses and data.
The patients' medical records are screened for exclusion criteria. Eligible patients are contacted and asked to come for a consultation regarding the risk of developing osteoporosis. The patients are contacted directly if they visit the clinic anyway; otherwise they are contacted by e-mail or letter.
Patients coming for a consultation are given a questionnaire regarding osteoporosis risk factors in relation to lifestyle, diet, diseases predisposing osteoporosis, fall prophylaxis, and medication. The questionnaire also evaluate the patient's attitude towards being offered preventive examination and treatment by his/hers general practitioner. Patients wanting a consultation, but not wishing to participate in the scientific study are examined and offered treatment equal to the consenting patient according to national standards.
The patients then have a consultation regarding osteoporosis prevention (typically by a nurse). During the consultation the patient's different risk factors are discussed and advice is given regarding fall prophylaxis, diet, calcium and vitamin D. The patient's medication is examined as specified by national guidelines. All patients are then offered referral to a DXA-scan.
Patients that are scanned and classified as having osteoporosis are offered a new consultation regarding osteoporosis treatment and blood tests for secondary osteoporosis screening purposes.
Patients with osteopenia and normal bone mineral density are informed about their test result and if necessary advised to have a new DXA-scan in a few years.
The study is based on the routine identification of patients at risk of osteoporosis found by using the Sentinel data capture program. Intervention is not used in the study, however the patients at risk are offered regular preventive examination according to their risk (DXA-scan). The study analyses data based on the quality assurance work regarding osteoporosis of the general practices.
Patients are informed that participation is completely voluntary and they can withdraw from the study at any time and it will have no bearing on present or future treatment. All participating patients give oral and written informed consent.
Patients not wanting to participate will not be part of the study and only their sex, age, risk factors and reason for exclusion will be registered anonymously in order to evaluate the selection of patients.
Lack of participation in the study will have no consequences on the examination and treatment offered to patients at risk.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at list at the participating general pracitices who are identified to be at an increased risk of osteoporosis by the data capture program are invited to participate (by direct contact, mail or e-mail)
Key inclusion criteria (1 listed)
- Patient identified as being at an increased risk of osteoporosis by the data capture system
Key exclusion criteria (9 listed)
- Known osteoporosis.
- Patients treated with alendronate.
- Patients below 25 years of age.
- Bone metastasis.
- Terminal disease.
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
Number of patients with osteoporosis
Time frame: 6 weeks after visit at the GP clinic
Participating patients are referred to a bone mineral density measurement (DXA scan). The exact time depends on the waiting time for bone mineral density Measurements.
2 secondary outcomes
Number of patients with osteopenia
Time frame: 6 weeks after visit at the GP clinic
Cost of identifying a patient with osteoporosis
Time frame: 2 weeks after bone mineral density measurment
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 19 Jul 2016.
- Individual participant dataSharing planned: No
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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.
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, run by Aalborg University at 1 site 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 9 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 19 Jul 2016. 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 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 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?
Number of patients with osteoporosis (time frame: 6 weeks after visit at the GP clinic). 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 19 Jul 2016; AzTrials last refreshed its copy on 30 Oct 2026.