Osteoporotic FracturesSAOSNCT04565743
Stop At One Stockholm (SAOS)- Secondary Fracture Prevention Through Active Patient Identification and Staff Education.
A study testing Support on dentification and treatment of patients with high risk of osteoporotic fractures in people with Osteoporotic Fractures and Osteoporosis, run by Helena Salminen at 1 site in Sweden.
Trial summary
This is a study on the effects of education on secondary fracture prevention in primary health care centers (PHCC) and referral from hospitals to these PHCC of patients with recent fragility fractures. The design is Cluster-randomized controlled study with two arms. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoporotic Fractures, Osteoporosis, Osteoporosis Risk
- What is being tested?
- Support on dentification and treatment of patients with high risk of osteoporotic fractures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2018to 10 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a diagnose at a medical care unit within Stockholm county on a low energy fracture of hip, pelvis, spine, proximal humerus och distal radius between three months before study start an end of study.
- Patient is enlisted at one of the PHCCs in the interventional arm of the study
- Patent is aged 60 years or older
Who cannot join
- The patient has after the index fracture, already been referred to the correct primary health care center for secondary fracture prevention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stop At One Stockholm: Co-operation Between Health Care Providers and Medical Education in Primary Health Care to Prevent Falls and Fractures in the Elderly
This is a study on the effects of education on secondary fracture prevention in primary health care centers (PHCC) and referral from hospitals to these PHCC of patients with recent fragility fractures.
The design is Cluster-randomized controlled study with two arms. 40 primary health care centers (PHCC) are included, each PHCC constitutes a cluster. The intervention group contains 20 PHCCs and the control group of the remaining 20 PHCCs. The educational part of the intervention is divided into three sessions; one web based course succeeded by two multiprofessional seminars with six months interval. During the intervention period patients enlisted at the intervention PHCCs, aged 60 or more who are diagnosed on a fragility fracture are referred to their respective PHCC. The primary outcome are the proportions of patients who receive bone specific treatment after their fracture in the intervention group compared to the control group.
Read the detailed description
Fragility fractures are in this study defined as a fracture of the spine, hip, pelvis, proximal humerus och distal radius caused by low energy trauma. A trauma not exceeding the force implied on the body from a fall from standing height on a flat surface, is regarded to be a low energy trauma.
The educational intervention targets general practitioners and nurses from the PHCC as well as physiotherapists, occupational therapists and dietitians from a nearby rehabilitation centre.
All professions go through the same web course before educational session #1 which is held at the PHCC. The web course includes basic knowledge about risk factors for fragility fractures
At session #1 all professions first participate in a common seminar of 45 minutes. After that physicians, nurses and rehabilitation related professions each have an additional seminar of 45 minutes, that means three separate seminars. Three teachers lead the seminars; a specialist in family medicine, a nurse specialized in primary care and a physiotherapist. They are all present during all of the seminars at each PHCC and the same three individuals leads the seminars at all PHCCs. The seminars focus on identification of persons at high risk of fracture and different methods to lower that risk. The importance of multiprofessional care for these patients is stressed. The participants are given opportunity to discuss how they might facilitate cooperation between the different health vare professions. Development of local routines for multiprofessional care is encouraged.
Educational session #2 is held approximally 6 months after session #1. Session #2 invites the same health care professionals as session #1. There are three parts. A first part of 45 minutes for the physicians and nurses. A second part of 45 minutes where personnel from the rehabilitation center joins. The third part of 45 minutes includes just the rehabilitation personnel.
At session #2 includes a short review of the contents discussed in session #1. The focus however is on the development of new local routines to secure the ability for patients with a high risk of fracture to be offered multiprofessional care. What needs to be done and who does what at your PHCC/rehabilitation center? The participants also get feedback on the number of patients being treated with bone-specific drugs before and after the start of the intervention.
Inclusion of patients stops at december 1 2020. Referrals to the PHCC of the patients included last will be conducted during January 2021.
Primary outcome data is gathered at each PHCC from the medical journals of the enlisted patients aged >60 with fragility fractures. Data includes the time frame one year before start of study, until two years after the last patient was included.
Secondary outcomes, fractures and fall related injuries will be collected from National health care registers, three and five years after the last patient was included.
- Conditions
- Osteoporotic Fractures, Osteoporosis, Osteoporosis Risk
- Being tested
- Support on dentification and treatment of patients with high risk of osteoporotic fractures
- Keywords
- Organization & administration, Secondary prevention, Bone Density Conservation Agents
- Medical subject headings
- Osteoporotic Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support on dentification and treatment of patients with high risk of osteoporotic fracturesBehavioural
Education for primary care health care professionals and referral of patients with recent osteoporotic fracture.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Multiprofessional education for health professionals in primary care on secondary prevention of osteoporotic fractures. Identification and referral of patients with recent osteoporotic fracture. Receives: Behavioral: Support on dentification and treatment of patients with high risk of osteoporotic fractures |
| Control | No intervention | No intervention from study. No restrictions regarding education or the local organization of care for the prevention of osteoporotic fractures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants treated with bone specific drugs after first fragility fracture at different points in time up to three years after inclusion.
Participants are included in the study at the date of their first fragility fracture within the study period. The proportion of participants treated with bone-specific drugs any time since the fracture date, will be measured every 6 months during the study period.
Measured: Three years after inclusion of study participant
Secondary outcomes (1)
Proportion of participants treated with calcium and vitamin D but not bone specific drugs after first fragility fracture at different points in time after inclusion up to three years after inclusion.
Participants are included in the study at the date of their first fragility fracture within the study period. The proportion of participants treated with Calcium and vitamin D supplements but not simultaneously with bone-specific drugs at any time since the fracture date, will be measured until three years after inclusion.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Feb 2018
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FracturesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled study. 40 clusters with an estimated cluster size of 90 participating individuals in each cluster.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helena Salminen
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Sponsor-investigator, Helena Salminen, Karolinska Institutet
- Investigators
- Helena Salminen, MD, Ass Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565743
- Sponsor's protocol ID
- 2018/927-31/2
- Acronym
- SAOS
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2020
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop At One Stockholm: Co-operation Between Health Care Providers and Medical Education in Primary Health Care to Prevent Falls and Fractures in the Elderly
- ClinicalTrials.gov ID
- NCT04565743
- Acronym / sponsor ID
- SAOS / 2018/927-31/2
- Conditions
- Osteoporotic Fractures, Osteoporosis, Osteoporosis Risk
- Keywords
- Organization & administration, Secondary prevention, Bone Density Conservation Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Helena SalminenUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 25 Sep 2020 (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.
This is a study on the effects of education on secondary fracture prevention in primary health care centers (PHCC) and referral from hospitals to these PHCC of patients with recent fragility fractures.
The design is Cluster-randomized controlled study with two arms. 40 primary health care centers (PHCC) are included, each PHCC constitutes a cluster. The intervention group contains 20 PHCCs and the control group of the remaining 20 PHCCs. The educational part of the intervention is divided into three sessions; one web based course succeeded by two multiprofessional seminars with six months interval. During the intervention period patients enlisted at the intervention PHCCs, aged 60 or more who are diagnosed on a fragility fracture are referred to their respective PHCC. The primary outcome are the proportions of patients who receive bone specific treatment after their fracture in the intervention group compared to the control group.
Detailed description
Fragility fractures are in this study defined as a fracture of the spine, hip, pelvis, proximal humerus och distal radius caused by low energy trauma. A trauma not exceeding the force implied on the body from a fall from standing height on a flat surface, is regarded to be a low energy trauma.
The educational intervention targets general practitioners and nurses from the PHCC as well as physiotherapists, occupational therapists and dietitians from a nearby rehabilitation centre.
All professions go through the same web course before educational session #1 which is held at the PHCC. The web course includes basic knowledge about risk factors for fragility fractures
At session #1 all professions first participate in a common seminar of 45 minutes. After that physicians, nurses and rehabilitation related professions each have an additional seminar of 45 minutes, that means three separate seminars. Three teachers lead the seminars; a specialist in family medicine, a nurse specialized in primary care and a physiotherapist. They are all present during all of the seminars at each PHCC and the same three individuals leads the seminars at all PHCCs. The seminars focus on identification of persons at high risk of fracture and different methods to lower that risk. The importance of multiprofessional care for these patients is stressed. The participants are given opportunity to discuss how they might facilitate cooperation between the different health vare professions. Development of local routines for multiprofessional care is encouraged.
Educational session #2 is held approximally 6 months after session #1. Session #2 invites the same health care professionals as session #1. There are three parts. A first part of 45 minutes for the physicians and nurses. A second part of 45 minutes where personnel from the rehabilitation center joins. The third part of 45 minutes includes just the rehabilitation personnel.
At session #2 includes a short review of the contents discussed in session #1. The focus however is on the development of new local routines to secure the ability for patients with a high risk of fracture to be offered multiprofessional care. What needs to be done and who does what at your PHCC/rehabilitation center? The participants also get feedback on the number of patients being treated with bone-specific drugs before and after the start of the intervention.
Inclusion of patients stops at december 1 2020. Referrals to the PHCC of the patients included last will be conducted during January 2021.
Primary outcome data is gathered at each PHCC from the medical journals of the enlisted patients aged >60 with fragility fractures. Data includes the time frame one year before start of study, until two years after the last patient was included.
Secondary outcomes, fractures and fall related injuries will be collected from National health care registers, three and five years after the last patient was included.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled study. 40 clusters with an estimated cluster size of 90 participating individuals in each cluster.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Support on dentification and treatment of patients with high risk of osteoporotic fracturesMultiprofessional education for health professionals in primary care on secondary prevention of osteoporotic fractures. Identification and referral of patients with recent osteoporotic fracture. |
| Control | No intervention | –No intervention from study. No restrictions regarding education or the local organization of care for the prevention of osteoporotic fractures. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has a diagnose at a medical care unit within Stockholm county on a low energy fracture of hip, pelvis, spine, proximal humerus och distal radius between three months before study start an end of study.
- Patient is enlisted at one of the PHCCs in the interventional arm of the study
- Patent is aged 60 years or older
Key exclusion criteria (1 listed)
- The patient has after the index fracture, already been referred to the correct primary health care center for secondary fracture prevention.
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 |
|---|---|---|
| Support on dentification and treatment of patients with high risk of osteoporotic fracturesEducation for primary care health care professionals and referral of patients with recent osteoporotic fracture. | Behavioural | Intervention |
Primary outcome
Proportion of participants treated with bone specific drugs after first fragility fracture at different points in time up to three years after inclusion.
Time frame: Three years after inclusion of study participant
Participants are included in the study at the date of their first fragility fracture within the study period. The proportion of participants treated with bone-specific drugs any time since the fracture date, will be measured every 6 months during the study period.
1 secondary outcome
Proportion of participants treated with calcium and vitamin D but not bone specific drugs after first fragility fracture at different points in time after inclusion up to three years after inclusion.
Time frame: Three years
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 25 Aug 2026.
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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.
Helena Salminen, MD, Ass Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support on dentification and treatment of patients with high risk of osteoporotic fractures in people with Osteoporotic Fractures and Osteoporosis, run by Helena Salminen at 1 site 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 3 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 25 Aug 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 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?
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?
Proportion of participants treated with bone specific drugs after first fragility fracture at different points in time up to three years after inclusion. (time frame: Three years after inclusion of study participant). 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 25 Aug 2026.