Low Trauma Non Vertebral FractureOstéo-SMSNCT01915745
Study of Current Practice Evaluating the Efficacy of a Mobile Short Message Service (SMS) on Post-fracture Management.
A study testing Use of SMS in people with Low Trauma Non Vertebral Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of the study is to show that the standardized sending of SMS improve the bone mineral density (BMD) screening of patients seen in the Emergency department for low trauma fracture. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Low Trauma Non Vertebral Fracture
- What is being tested?
- Use of SMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of more than 50 years old
- Low trauma non vertebral fracture
- Ambulatory patient
- Direct access to mobile phone (or access with the help of a close person) and ability to communicate via SMS.
- Patient who doesn't oppose to his participation in the study
- Affiliation to the social security
Who cannot join
- Patients hospitalized for the fracture in the orthopaedics department because these more severe patients have a systematic screening and management of osteoporosis.
- Fractures whose location is not suggestive of osteoporotic fracture (cervical spine, skull, hands, fingers, toes)
- Pathological fractures (cancer or myeloma)
- Traumatic fractures
- Severe alterations of cognitive functions
- Resident subjects except Paris and the surrounding area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of a Mobile Phone Short Message Service on Post-fracture Management for Patients Who Consult to the Emergency Department
The purpose of the study is to show that the standardized sending of SMS improve the bone mineral density (BMD) screening of patients seen in the Emergency department for low trauma fracture.
Read the detailed description
Osteoporosis is a significant health problem in the older population affecting at least 40% of women and 15 % of men over the age of 50 years. Fracture leads to increased morbidity and mortality and healthcare costs as well as predisposing to future fractures. Patients with a history of low-energy fracture are at significantly increased risk for further fractures in the short-term. There is a universal consensus supported by high-quality randomized trial evidence for secondary prevention: patients with low-trauma fragility fractures should have BMD testing and most of them would benefit from anti-osteoporotic treatment There is, unfortunately, also a well-documented and near-universal gap between evidence-based best practice and usual care for patients with fragility fractures. Although osteoporotic fracture indicates a two- to threefold increased risk of future fracture, only one in five patients receive medical intervention after sustaining an osteoporotic fracture. Diverse post fracture interventions have been developed for improving osteoporosis diagnosis and treatment: provided educational materials to patients and/or primary physician, use of medical reminders, more intensive interventions using osteoporosis case manager (nurse, doctor) and fracture liaison service. the most effective post fracture interventions are those which are more proactive, complex, time consuming, coordinator manager dependant, and costly. Taking account the costs and the humans resources needing, we propose to improve post fracture patient management using mobile telecommunication already used for other chronic diseases management. There is no study about the use of phone short message service (SMS) support in the field of osteoporosis, especially in the post-fracture management: bone mineral density (BMD) screening, anti-osteoporotic treatment initiation and monitoring and improvement of adherence. One of the limitations could be the use of phone mobile in these older patients. We assessed the number of mobile phone users among 100 consecutive subjects who were hospitalized for non vertebral fracture (mean age 69.5 years (50-98); 58 women and 42 men) in the Emergency department of Cochin hospital: 61 % had a mobile phone and used SMS; 61% have a mobile phone.
We propose to assess the efficacy of the use of SMS support to improve the screening and the initiation of antiosteoporotic treatment in patients with low trauma non vertebral fracture, who consult in Emergency department.
This is a study of current care, monocentric, randomized, open. 170 patients will be followed for 6 months. The group control will receive the usual recommendations to make an appointment of realization of bone densitometry. The SMS group will receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting the time of consultation in Emergency department, and will be called during 10 minutes at 6 months by a nurse.
The results of this study will have an important impact for the postfracture management in the field of osteoporosis . Indeed, if we demonstrate that the use of SMS improves the BMD screening and antiosteoporotic treatment initiation, we plan to assess in a large randomized controlled trial whether mobile phone communication can decrease the risk of new fracture comparatively to usual care in patients with low trauma fracture could use.
- Conditions
- Low Trauma Non Vertebral Fracture
- Being tested
- Use of SMS
- Keywords
- Osteoporosis, Bone densitometry, Fracture, Anti-osteoporotic treatment, Short message service
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of SMSOther
Also called Sending of 3 SMS to remind to the patient to perform bone densitometry.
Patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in Emergency Department. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated.
| Study group | Role | What they receive |
|---|---|---|
| Usually health care | No intervention | 85 patients receive the usually health care. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated. |
| Short Message Service - SMS | Experimental | 85 patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in the Emergency Department emergencies. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated. Receives: Other: Use of SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Realisation of bone densitometry
Realisation of a bone densitometry within 6 months after the consultation in the Emergency Department
Measured: 6 months
Secondary outcomes (1)
The initiation of a treatment anti-osteoporotic
Initiation of a treatment anti-osteoporotic (calcium and/or vitamine D, raloxifene, bisphosphonates, teriparatide, ranelate de strontium, denosumab) within 6 months after the consultation in the Emergency Department for low trauma fracture.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Trauma Non Vertebral FractureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Karine BRIOT, MD, PhD, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915745
- Sponsor's protocol ID
- K120601
- Other IDs
- 2012-A01135-38
- Acronym
- Ostéo-SMS
- Status last verified
- Oct 2025
- First submitted
- 2 Aug 2013
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Mobile Phone Short Message Service on Post-fracture Management for Patients Who Consult to the Emergency Department
- ClinicalTrials.gov ID
- NCT01915745
- Acronym / sponsor ID
- Ostéo-SMS / K120601
- Conditions
- Low Trauma Non Vertebral Fracture
- Keywords
- Osteoporosis, Bone densitometry, Fracture, Anti-osteoporotic treatment, Short message service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Aug 2013 (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.
The purpose of the study is to show that the standardized sending of SMS improve the bone mineral density (BMD) screening of patients seen in the Emergency department for low trauma fracture.
Detailed description
Osteoporosis is a significant health problem in the older population affecting at least 40% of women and 15 % of men over the age of 50 years. Fracture leads to increased morbidity and mortality and healthcare costs as well as predisposing to future fractures. Patients with a history of low-energy fracture are at significantly increased risk for further fractures in the short-term. There is a universal consensus supported by high-quality randomized trial evidence for secondary prevention: patients with low-trauma fragility fractures should have BMD testing and most of them would benefit from anti-osteoporotic treatment There is, unfortunately, also a well-documented and near-universal gap between evidence-based best practice and usual care for patients with fragility fractures. Although osteoporotic fracture indicates a two- to threefold increased risk of future fracture, only one in five patients receive medical intervention after sustaining an osteoporotic fracture. Diverse post fracture interventions have been developed for improving osteoporosis diagnosis and treatment: provided educational materials to patients and/or primary physician, use of medical reminders, more intensive interventions using osteoporosis case manager (nurse, doctor) and fracture liaison service. the most effective post fracture interventions are those which are more proactive, complex, time consuming, coordinator manager dependant, and costly. Taking account the costs and the humans resources needing, we propose to improve post fracture patient management using mobile telecommunication already used for other chronic diseases management. There is no study about the use of phone short message service (SMS) support in the field of osteoporosis, especially in the post-fracture management: bone mineral density (BMD) screening, anti-osteoporotic treatment initiation and monitoring and improvement of adherence. One of the limitations could be the use of phone mobile in these older patients. We assessed the number of mobile phone users among 100 consecutive subjects who were hospitalized for non vertebral fracture (mean age 69.5 years (50-98); 58 women and 42 men) in the Emergency department of Cochin hospital: 61 % had a mobile phone and used SMS; 61% have a mobile phone.
We propose to assess the efficacy of the use of SMS support to improve the screening and the initiation of antiosteoporotic treatment in patients with low trauma non vertebral fracture, who consult in Emergency department.
This is a study of current care, monocentric, randomized, open. 170 patients will be followed for 6 months. The group control will receive the usual recommendations to make an appointment of realization of bone densitometry. The SMS group will receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting the time of consultation in Emergency department, and will be called during 10 minutes at 6 months by a nurse.
The results of this study will have an important impact for the postfracture management in the field of osteoporosis . Indeed, if we demonstrate that the use of SMS improves the BMD screening and antiosteoporotic treatment initiation, we plan to assess in a large randomized controlled trial whether mobile phone communication can decrease the risk of new fracture comparatively to usual care in patients with low trauma fracture could use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usually health care | No intervention | –85 patients receive the usually health care. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated. |
| Short Message Service - SMS | Experimental | Other: Use of SMS85 patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in the Emergency Department emergencies. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of more than 50 years old
- Low trauma non vertebral fracture
- Ambulatory patient
- Direct access to mobile phone (or access with the help of a close person) and ability to communicate via SMS.
- Patient who doesn't oppose to his participation in the study
Key exclusion criteria (6 listed)
- Patients hospitalized for the fracture in the orthopaedics department because these more severe patients have a systematic screening and management of osteoporosis.
- Fractures whose location is not suggestive of osteoporotic fracture (cervical spine, skull, hands, fingers, toes)
- Pathological fractures (cancer or myeloma)
- Traumatic fractures
- Severe alterations of cognitive functions
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 |
|---|---|---|
| Use of SMSAlso: Sending of 3 SMS to remind to the patient to perform bone densitometry.Patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in Emergency Department. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated. | Other | Short Message Service - SMS |
Primary outcome
Realisation of bone densitometry
Time frame: 6 months
Realisation of a bone densitometry within 6 months after the consultation in the Emergency Department
1 secondary outcome
The initiation of a treatment anti-osteoporotic
Time frame: 6 months
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 20 Nov 2025.
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.
Karine BRIOT, MD, PhD principal investigator
Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of SMS in people with Low Trauma Non Vertebral Fracture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 6 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 20 Nov 2025. 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 France. 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?
Realisation of bone densitometry (time frame: 6 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 20 Nov 2025.