OsteoporosisRCT-PATOSNCT07367776
Patient Education in Osteoporosis (RCT-PATOS)
A study testing Digital patient education, Face-to-face patient education and General information on osteoporosis (open website) in people with Osteoporosis, run by University Hospital, Linkoeping at 7 sites in Sweden.
Trial summary
The objective of this randomized clinical trial is to assess both the effectiveness and underlying mechanisms of patient education for individuals aged 50 years and older with osteoporosis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Digital patient education, Face-to-face patient education and General information on osteoporosis (open website)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 7 sitesSweden
- Study dates
- 27 Jan 2026to 20 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Women and men
- Age > 50 years
- Diagnosed with osteoporosis or osteopenia (either ICD-coded [M80x, M81x, or M859] or current/previous pharmacological treatment for osteoporosis)
- Basic computer literacy
- Possession of BankID (Swedish electronic identification system used for secure authentication) and ability to log in to the 1177.se "Support and Treatment platform"
Who cannot join
- Inability to understand written and spoken Swedish
- Cognitive impairment preventing comprehension of the study protocol and provision of informed consent
- Participation in structured patient education on osteoporosis within the past year
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Sweden7 sites, 7 recruiting
- Recruiting
Region Gävleborg
Gävle
Research coordinator at Linköpings University Hospital, +46-10-1030000, osteoporosforskning@regionostergotland.se
- Recruiting
Region Jönköpings län
Jönköping
Research coordinator at Linköpings University Hospital, +46-10-1030000, osteoporosforskning@regionostergotland.se
- Recruiting
Region Kalmar
Kalmar
Research coordinator at Linköpings University Hospital, +46-10-1030000, osteoporosforskning@regionostergotland.se
- Recruiting
Region Sörmland
Katrineholm
Research coordinator at Linköpings University Hospital, +46-10-1030000, osteoporosforskning@regionostergotland.se
- Not yet recruiting
Region Halland
Kungsbacka
Research coordinator at Linköpings University Hospital, +46-10-1030000, osteoporosforskning@regionostergotland.se
- Recruiting
Region Östergötland
Linköping
Research coordinator at Linköpings University Hospital, +46-10-1030000, osteoporosforskning@regionostergotland.se
- Recruiting
Region Örebro
Örebro
Research coordinator at Linköpings University Hospital, +46-10-1030000, osteoporosforskning@regionostergotland.se
About this study
Official title: Effects and Mechanisms of Patient Education in Osteoporosis: A Randomized Controlled Trial Comparing Digital Education, Face-to-Face Education, and General Patient Information (RCT-PATOS)
The objective of this randomized clinical trial is to assess both the effectiveness and underlying mechanisms of patient education for individuals aged 50 years and older with osteoporosis.
Primary research question: What differences in outcomes can be observed among three different educational interventions with respect to osteoporosis-specific self-care, health related quality of life, fracture risk, illness perception, physical activity, physical function, fear of falling, and pain in patients diagnosed with osteoporosis?
Read more
The trial will include three study arms: 1) Control group: Participants receive standard osteoporosis information provided by healthcare services. 2) Face-to-face education: Three 2-hours sessions led by a physiotherapist (two sessions) and physician or nurse (one session) within a 2 months period. 3) Digital education: Internet-based program consisting of nine modules accessible to participants over a one-year period.
Participants will complete questionnaires and undergo physical assessments at baseline, and at 3 and 12 months follow up. Additionally, a subset of participants will undergo objective assessment of physical activity pattern and sedentary behaviours with an accelerometer at baseline and after 3 and 12 months.
- Conditions
- Osteoporosis
- Being tested
- Digital patient education, Face-to-face patient education, General information on osteoporosis (open website)
- Keywords
- osteoporosis, patient education, self-care, health related quality of life, HRQoL, internetbased, digital
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital patient educationBehavioural
An internet-based program comprising nine modules will be available to participants for a duration of one year. The program addresses essential components of patient education in osteoporosis and includes a variety of learning formats such as text, images, videos, reflection exercises, knowledge-check questions, and checklists. The estimated total time required to complete the program is approximately 5.5 hours. Intervention adherence will be monitored. For the digital intervention, adherence will be assessed by number of modules accessed.
Face-to-face patient educationBehavioural
Three theoretical sessions, each lasting two hours, will be conducted over a period of 3-5 weeks. The sessions adhere to a standardized curriculum addressing key aspects of osteoporosis management. Two sessions will be led by physiotherapists, and one session by either a physician or a nurse. Each group will include a maximum of 15 participants. Intervention adherence will be monitored. For the group-based intervention, attendance at scheduled sessions will be recorded.
General information on osteoporosis (open website)Behavioural
Participants receive general osteoporosis information provided by healthcare services (open website with general information on osteoporosis: https://www.1177.se/sjukdomar--besvar/skelett-leder-och-muskler/benskorhet---osteoporos/ ).
| Study group | Role | What they receive |
|---|---|---|
| Usual care (Control) | Active comparator | General information on osteoporosis (open website) Receives: Behavioral: General information on osteoporosis (open website) |
| Face-to-face patient education | Active comparator | Structured group-based theoretical education ('osteoporosis school') Receives: Behavioral: Face-to-face patient education |
| Digital patient education | Active comparator | Internet-based patient education program Receives: Behavioral: Digital patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months)
The OsCare questionnaire is a self-administered assessment designed to evaluate patients' knowledge, motivation, and behavior related to osteoporosis management. It consists of items rated on an ordinal scale, where higher values indicate more favorable responses. The instrument yields both an overall score reflecting the general level of osteoporosis-related self-care, and subscale scores corresponding to the individual domains (knowledge, motivation, and behavior).
Measured: Baseline to follow up at 12 months.
Secondary outcomes (20)
Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 3 months)
The OsCare questionnaire is a self-administered assessment designed to evaluate patients' knowledge, motivation, and behavior related to osteoporosis management. It consists of items rated on an ordinal scale, where higher values indicate more favorable responses. The instrument yields both an overall score reflecting the general level of osteoporosis-related self-care, and subscale scores corresponding to the individual domains (knowledge, motivation, and behavior).
Measured: Baseline to follow-up at 3 months.
Health-related quality of life (HRQoL) - RAND-36
Assessed with RAND 36-Item Health Survey. The RAND-36 compromises 36 items covering 8 health-related domains.
Measured: Baseline to follow-up at 3 months and 12 months.
Health-related quality of life (HRQoL) - EQ-5D-5L
Assessed with the EuroQol 5 Dimensions (EQ5D-5L) and Visual Analogue Scale (VAS 0-100) where respondents rate their overall health.
Measured: Baseline to follow-up at 3 months and 12 months.
Patient enablement instrument (PEI)
Measured with the Patient Enablement Instrument (PEI).
Measured: 3 months and 12 months
Fear of falling
Assessed with Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire.
Measured: Baseline to follow-up at 3 months and 12 months.
Illness perception
Assessed with the Brief-Illness Perception Questionnaire BIPQ which is an 8-item questionnaire.
Measured: Baseline to follow-up at 3 months and 12 months.
Beliefs about the necessity of prescribed medication
Assessed using Beliefs about Medicines Questionnaire (BMQ).
Measured: Baseline to follow-up at 3 months and 12 months.
Physical activity (self-reported)
Measured with questions from the Swedish Questionnaire about Lifestyle Habits.
Measured: Baseline to follow-up at 3 months and 12 months.
Fall incidence (self-reported)
Self-reported numbers of fall during the last 3 and 12 months
Measured: Baseline to follow-up at 3 months and 12 months.
Perceived balance (self-reported)
Self-rated perceived balance is assessed with Numeric Rating Scale (NRS 0-10).
Measured: Baseline to follow-up at 3 months and 12 months.
Perceived pain (self-reported)
Self-reported pain is assessed both regarding intensity (Numeric Rating Scale [NRS] 0-10) and frequency.
Measured: Baseline to follow-up at 3 months and 12 months.
Use of pain-relieving medication (self-reported)
Self-reported use of pain-relieving medication, including type and frequency.
Measured: Baseline to follow-up at 3 months and 12 months.
Fracture risk score
Composite score based on results for balance (One-leg-standing test with eyes opened), leg muscle srength (Chair-Stand test- 30 sec), and patient-reported fall incidence during the last year.
Measured: Baseline to follow-up at 3 months and 12 months.
Maximal walking speed
Walking speed assessed with patients walking 10 meters at a maximal walking speed.
Measured: Baseline to follow-up at 3 months and 12 months.
Hand-strength
Assessed in sitting position with the Jamar. Values from both right and left side are assessed.
Measured: Baseline to follow-up at 3 months and 12 months.
Chair-Stand test (30 sec)
The maximal number of sit to stand during 30 seconds.
Measured: Baseline to follow-up at 3 months and 12 months.
Measure of hyperkyfosis
With patients in upright standing measuring distance between the C7 and the wall
Measured: Baseline to follow-up at 3 months and 12 months.
Timed-up and go (TUG)
Patients were asked to stand up from sitting and walk 3 meters, turning around, walk back and sit again. Time was measured in seconds.
Measured: Baseline to follow-up at 3 months and 12 months.
Static balance
Assessed with the One-leg-Standing test with eyes opened (OLST-EO) for both right and left legs and a maximum of 60 seconds.
Measured: Baseline to follow-up at 3 months and 12 months.
Dynamic balance
Measured with the Four Square Step Test (FSST) as the time in seconds to perform a sequence that require the subject to step forward, backward, and sideway to the right and left.
Measured: Baseline to follow-up at 3 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start27 Jan 2026
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Oct 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro County Council, Region Kalmar County, County Council of Halland, Sweden, Sormland County Council, Sweden, County Council of Gavleborg, Region Jönköping County
- Responsible party
- Principal investigator, Anna Spangeus, University Hospital, Linkoeping
- Investigators
- Anna Spångeus, Ass Prof MD, Study chair, Region ÖstergötlandJohanna Wibault, PhD, Principal investigator, Region ÖstergötlandGunnel Peterson, Assoc Prof, Principal investigator, Sormland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367776
- Sponsor's protocol ID
- RCT-PATOS
- Acronym
- RCT-PATOS
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Patient Education in Osteoporosis: A Randomized Controlled Trial Comparing Digital Education, Face-to-Face Education, and General Patient Information (RCT-PATOS)
- ClinicalTrials.gov ID
- NCT07367776
- Acronym / sponsor ID
- RCT-PATOS / RCT-PATOS
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, patient education, self-care, health related quality of life, HRQoL, internetbased, digital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Örebro County Council, Region Kalmar County, County Council of Halland, Sweden, Sormland County Council, Sweden, County Council of Gavleborg, Region Jönköping County
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 20 Oct 2028 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 26 Jan 2026 (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.
The objective of this randomized clinical trial is to assess both the effectiveness and underlying mechanisms of patient education for individuals aged 50 years and older with osteoporosis.
Primary research question: What differences in outcomes can be observed among three different educational interventions with respect to osteoporosis-specific self-care, health related quality of life, fracture risk, illness perception, physical activity, physical function, fear of falling, and pain in patients diagnosed with osteoporosis?
The trial will include three study arms: 1) Control group: Participants receive standard osteoporosis information provided by healthcare services. 2) Face-to-face education: Three 2-hours sessions led by a physiotherapist (two sessions) and physician or nurse (one session) within a 2 months period. 3) Digital education: Internet-based program consisting of nine modules accessible to participants over a one-year period.
Participants will complete questionnaires and undergo physical assessments at baseline, and at 3 and 12 months follow up. Additionally, a subset of participants will undergo objective assessment of physical activity pattern and sedentary behaviours with an accelerometer at baseline and after 3 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care (Control) | Active comparator | Behavioral: General information on osteoporosis (open website)General information on osteoporosis (open website) |
| Face-to-face patient education | Active comparator | Behavioral: Face-to-face patient educationStructured group-based theoretical education ('osteoporosis school') |
| Digital patient education | Active comparator | Behavioral: Digital patient educationInternet-based patient education program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women and men
- Age > 50 years
- Diagnosed with osteoporosis or osteopenia (either ICD-coded [M80x, M81x, or M859] or current/previous pharmacological treatment for osteoporosis)
- Basic computer literacy
- Possession of BankID (Swedish electronic identification system used for secure authentication) and ability to log in to the 1177.se "Support and Treatment platform"
Key exclusion criteria (3 listed)
- Inability to understand written and spoken Swedish
- Cognitive impairment preventing comprehension of the study protocol and provision of informed consent
- Participation in structured patient education on osteoporosis within the past year
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 |
|---|---|---|
| Digital patient educationAn internet-based program comprising nine modules will be available to participants for a duration of one year. The program addresses essential components of patient education in osteoporosis and includes a variety of learning formats such as text, images, videos, reflection exercises, knowledge-check questions, and checklists. The estimated total time required to complete the program is approximately 5.5 hours. Intervention adherence will be monitored. For the digital intervention, adherence will be assessed by number of modules accessed. | Behavioural | Digital patient education |
| Face-to-face patient educationThree theoretical sessions, each lasting two hours, will be conducted over a period of 3-5 weeks. The sessions adhere to a standardized curriculum addressing key aspects of osteoporosis management. Two sessions will be led by physiotherapists, and one session by either a physician or a nurse. Each group will include a maximum of 15 participants. Intervention adherence will be monitored. For the group-based intervention, attendance at scheduled sessions will be recorded. | Behavioural | Face-to-face patient education |
| General information on osteoporosis (open website)Participants receive general osteoporosis information provided by healthcare services (open website with general information on osteoporosis: https://www.1177.se/sjukdomar--besvar/skelett-leder-och-muskler/benskorhet---osteoporos/ ). | Behavioural | Usual care (Control) |
Primary outcome
Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months)
Time frame: Baseline to follow up at 12 months.
The OsCare questionnaire is a self-administered assessment designed to evaluate patients' knowledge, motivation, and behavior related to osteoporosis management. It consists of items rated on an ordinal scale, where higher values indicate more favorable responses. The instrument yields both an overall score reflecting the general level of osteoporosis-related self-care, and subscale scores corresponding to the individual domains (knowledge, motivation, and behavior).
20 secondary outcomes
Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 3 months)
Time frame: Baseline to follow-up at 3 months.
Health-related quality of life (HRQoL) - RAND-36
Time frame: Baseline to follow-up at 3 months and 12 months.
Health-related quality of life (HRQoL) - EQ-5D-5L
Time frame: Baseline to follow-up at 3 months and 12 months.
Patient enablement instrument (PEI)
Time frame: 3 months and 12 months
Fear of falling
Time frame: Baseline to follow-up at 3 months and 12 months.
Illness perception
Time frame: Baseline to follow-up at 3 months and 12 months.
Beliefs about the necessity of prescribed medication
Time frame: Baseline to follow-up at 3 months and 12 months.
Physical activity (self-reported)
Time frame: Baseline to follow-up at 3 months and 12 months.
Fall incidence (self-reported)
Time frame: Baseline to follow-up at 3 months and 12 months.
Perceived balance (self-reported)
Time frame: Baseline to follow-up at 3 months and 12 months.
Perceived pain (self-reported)
Time frame: Baseline to follow-up at 3 months and 12 months.
Use of pain-relieving medication (self-reported)
Time frame: Baseline to follow-up at 3 months and 12 months.
Fracture risk score
Time frame: Baseline to follow-up at 3 months and 12 months.
Maximal walking speed
Time frame: Baseline to follow-up at 3 months and 12 months.
Hand-strength
Time frame: Baseline to follow-up at 3 months and 12 months.
Chair-Stand test (30 sec)
Time frame: Baseline to follow-up at 3 months and 12 months.
Measure of hyperkyfosis
Time frame: Baseline to follow-up at 3 months and 12 months.
Timed-up and go (TUG)
Time frame: Baseline to follow-up at 3 months and 12 months.
Static balance
Time frame: Baseline to follow-up at 3 months and 12 months.
Dynamic balance
Time frame: Baseline to follow-up at 3 months and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- 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.
Anna Spångeus, Ass Prof MD study chair
Region Östergötland
Johanna Wibault, PhD principal investigator
Region Östergötland
Gunnel Peterson, Assoc Prof principal investigator
Sormland County Council, Sweden
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital patient education, Face-to-face patient education and General information on osteoporosis (open website) in people with Osteoporosis, run by University Hospital, Linkoeping at 7 sites in Sweden.
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 5 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Spångeus, Ass Prof MD (+46-10-1030000, anna.spangeus@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months) (time frame: Baseline to follow up at 12 months.). 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 8 Sep 2026.