OsteoporosisNCT05401968
Osteoporosis Patient Education in Denmark
A study testing Osteoporosis patient education in people with Osteoporosis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
In an effect evaluation the investigators will examine the effects of participating in osteoporosis patient education. An intervention group who have already participated in patient education will be compared to a matched control group who have not participated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Osteoporosis patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,132 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Sep 2022to 1 Nov 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To participate in osteoporosis patient education in municipalities the participants should have osteoporosis or in few cases osteopenia.
Who cannot join
- None though this may vary across municipalities
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Institute of Public Health, University of Southern Denmark
Copenhagen
About this study
Official title: Osteoporosis Patient Education in Danish Municipalities: an Evaluation of Existing Programs and Recommendations for Further Practice
In an effect evaluation the investigators will examine the effects of participating in osteoporosis patient education. An intervention group who have already participated in patient education will be compared to a matched control group who have not participated. Effects on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence will be examined.
Read the detailed description
In this quasi-experimental study the investigators will conduct an effect evaluation that compares an intervention group of osteoporosis patients who have participated in patient education in a municipality with a control group who have not participated.
The intervention group consists of citizens who have already participated in osteoporosis patient education from 2016 until 2020. The investigators have received information on the intervention group from the municipalities who store data on previous participants.
The control group will be extracted via the Danish Health Data Authority and consists of citizens who have not participated in osteoporosis patient education. For each individual in the intervention group one control will be matched regarding gender, age, diagnosis, time of diagnose, and type of fracture before the index date (i.e. the date the individual in the intervention group started on patient education).
The aim of the effect evaluation is to examine the effects of osteoporosis patient education on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence.
Data is generated from a register extraction and a questionnaire-based survey. The questionnaire will include information on quality of life, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, and pain management. As far as possible validated questionnaires will be included to measure these outcomes. The register extraction will be made by the Danish Health Data Authority and include information on fractures and adherence.
All analyses are performed using Stata. In the analyses the investigators will compare the intervention group and the control group with regard to all outcomes. The covariates are selected on the basis of Directed Acyclic Graphs (DAG) and they include e.g. socioeconomic status, cohabitee status, and co-morbidity. The analysis will be completed on an intention to treat basis.
- Conditions
- Osteoporosis
- Being tested
- Osteoporosis patient education
- Keywords
- Patient education
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoporosis patient educationBehavioural
During osteoporosis patient education the participants get knowledge about e.g. osteoporosis, medication, and diet, and they participate in physical exercises. Though, differences between municipalities exist. The participants meet in groups and face-to-face.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Osteoporosis patients who have participated in patient education Receives: Behavioral: Osteoporosis patient education |
| Control group | No intervention | Osteoporosis patients who have not participated in patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in quality of life between intervention and control group
Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in clinical diagnosis of fracture between intervention and control group
Including hip, vertebral, forearm, and upper arm fractures registered in the National Patient Register
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Secondary outcomes (8)
Differences in daily functional capacity between intervention and control group
Measured with questions from the European Health Interview Survey
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in self-efficacy between intervention and control group
Measured with the questionnaire Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in psychological well-being between intervention and control group
Measured with the questionnaire Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in physical function between intervention and control group
Measured with questions from The Danish National Health Survey
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in balance between intervention and control group
Measured with self-constructed, validated questions regarding problems with balance and balance confidence
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in falls between intervention and control group
Measured with self-constructed, validated questions regarding number of falls and concerns about falling
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in pain management between intervention and control group
Measured with the Pain Self-Efficacy Questionnaire (PSEQ)
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group
Including adherence to alendronate and ibandronate attained from the Danish National Prescription Registry
Measured: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start19 Sep 2022
- Primary completion31 Dec 2022
- Study completion1 Nov 2025
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.
- More trials run by University of Southern DenmarkThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The municipalities recruit and include citizens in osteoporosis patient education. We have already received information on participants from 2016 until 2020, and thereafter we will create a matched control group, who have not participated in osteoporosis patient education.
- Masking
- None (open label)
- Enrolment
- 3,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Center for Bone Health
- Responsible party
- Sponsor
- Investigators
- Holmberg, Principal investigator, University of Southern DenmarkAndersen, Principal investigator, University of Southern DenmarkHitz, Principal investigator, National Research Center for Bone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401968
- Sponsor's protocol ID
- 19/33410
- Status last verified
- May 2026
- First submitted
- 23 May 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If possible, we will store data at The Danish National Archives. We will apply for storing at a later date.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Patient Education in Danish Municipalities: an Evaluation of Existing Programs and Recommendations for Further Practice
- ClinicalTrials.gov ID
- NCT05401968
- Acronym / sponsor ID
- 19/33410
- Conditions
- Osteoporosis
- Keywords
- Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,132 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- National Research Center for Bone Health
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 2 Jun 2022 (actual)
- 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 an effect evaluation the investigators will examine the effects of participating in osteoporosis patient education. An intervention group who have already participated in patient education will be compared to a matched control group who have not participated. Effects on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence will be examined.
Detailed description
In this quasi-experimental study the investigators will conduct an effect evaluation that compares an intervention group of osteoporosis patients who have participated in patient education in a municipality with a control group who have not participated.
The intervention group consists of citizens who have already participated in osteoporosis patient education from 2016 until 2020. The investigators have received information on the intervention group from the municipalities who store data on previous participants.
The control group will be extracted via the Danish Health Data Authority and consists of citizens who have not participated in osteoporosis patient education. For each individual in the intervention group one control will be matched regarding gender, age, diagnosis, time of diagnose, and type of fracture before the index date (i.e. the date the individual in the intervention group started on patient education).
The aim of the effect evaluation is to examine the effects of osteoporosis patient education on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence.
Data is generated from a register extraction and a questionnaire-based survey. The questionnaire will include information on quality of life, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, and pain management. As far as possible validated questionnaires will be included to measure these outcomes. The register extraction will be made by the Danish Health Data Authority and include information on fractures and adherence.
All analyses are performed using Stata. In the analyses the investigators will compare the intervention group and the control group with regard to all outcomes. The covariates are selected on the basis of Directed Acyclic Graphs (DAG) and they include e.g. socioeconomic status, cohabitee status, and co-morbidity. The analysis will be completed on an intention to treat basis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The municipalities recruit and include citizens in osteoporosis patient education. We have already received information on participants from 2016 until 2020, and thereafter we will create a matched control group, who have not participated in osteoporosis patient education.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Osteoporosis patient educationOsteoporosis patients who have participated in patient education |
| Control group | No intervention | –Osteoporosis patients who have not participated in patient education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- To participate in osteoporosis patient education in municipalities the participants should have osteoporosis or in few cases osteopenia.
Key exclusion criteria (1 listed)
- None though this may vary across municipalities
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 |
|---|---|---|
| Osteoporosis patient educationDuring osteoporosis patient education the participants get knowledge about e.g. osteoporosis, medication, and diet, and they participate in physical exercises. Though, differences between municipalities exist. The participants meet in groups and face-to-face. | Behavioural | Intervention group |
Primary outcome
Differences in quality of life between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)
Differences in clinical diagnosis of fracture between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Including hip, vertebral, forearm, and upper arm fractures registered in the National Patient Register
8 secondary outcomes
Differences in daily functional capacity between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in self-efficacy between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in psychological well-being between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in physical function between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in balance between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in falls between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in pain management between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group
Time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)
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 6 May 2026.
- Individual participant dataSharing planned: No. If possible, we will store data at The Danish National Archives. We will apply for storing at a later date.
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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.
Holmberg principal investigator
University of Southern Denmark
Andersen principal investigator
University of Southern Denmark
Hitz principal investigator
National Research Center for Bone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoporosis patient education in people with Osteoporosis, run by University of Southern Denmark 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 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: finished, as of the sponsor's last update on 6 May 2026. 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?
Differences in quality of life between intervention and control group (time frame: At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)). 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 6 May 2026.