Osteoporotic FracturesOPTIWORKNCT04781556
Impact of Osteoporotic Fractures on Work: Data From a Fracture Liaisons Service
An observational study of Osteoporotic Fractures, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Osteoporosis is a bone disease characterized by a decrease in bone density with deterioration of the micro-architecture and the appearance of bone fragility, responsible for an increased risk of fractures. The most common osteoporotic fractures are spinal, wrist and femoral neck fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoporotic Fractures
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2019to 21 Sep 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated between 01/01/2017 and 31/12/2018 in the Fracture sector will be screened through the computerized medical file
Who may be able to join
- Patients aged 18 to 65 at the time of the fracture
- French-speaking patient
- Patients treated in the Fracture Line between January 1, 2017 and December 31, 2018 for osteoporotic fracture
- Professionally active patients at the time of the fracture
Who cannot join
- Refusal to participate in the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
Osteoporosis is a bone disease characterized by a decrease in bone density with deterioration of the micro-architecture and the appearance of bone fragility, responsible for an increased risk of fractures. The most common osteoporotic fractures are spinal, wrist and femoral neck fractures. Osteoporosis affects 22.7% of women and 6.9% of men in France. Each year, around 8.9 million fragility fractures are identified worldwide, with an incidence in France in 2017 of 382,000 patients in France in 2017.
The economic impact, the functional consequences and the quality of life of patients with osteoporosis, fracture or not, have been widely described in the literature in recent years. There is indeed a great alteration in the mobility, functional capacities and overall quality of life of these patients, measured by composite scores such as Short Form-36 (SF-36), EuroQol 5 Dimensions (EQ-5D) , the Health-related quality of life (HRQoL), or more specifically for osteoporosis, osteoporososis quality of life questionnaire (OQLQ) or its shortened version OLQ, the osteoporosis assessment questionnaire (OPAQ), the Quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (specific for vertebral fractures), etc.
However, few studies have focused on the repercussions of osteoporotic fractures at work, because this pathology affects more elderly subjects (> 65 years old) and therefore retirees.
Read the detailed description
New osteoporosis management programs have emerged in recent years, in order to improve the management of this pathology by linking the specialties concerned. Among them, La Filière Fracture (in Anglo-Saxon: Fractures Liaisons Services: FLS) of the Paris Saint-Joseph Hospital Group (GHPSJ), created in 2015, aims to follow up patients consulting the GHPSJ for an osteoporotic fracture of spinal location. , the upper end of the femur or the lower end of the radius.
Since the creation of the sector, 2,486 patients have been recruited; it was found that in 529 of these patients (or 21.3%), the osteoporotic fracture occurred at an age of less than 65 years.
The impact on the work of an osteoporotic fracture has been little studied in the literature: a study focused specifically on fractures of the upper extremity of the femur, and found, in 291 patients under 65 years recruited between 2009 and 2013, a 65% return to work rate at 12 months, or around a third of patients who have not returned to professional activity at one year. A study published in 2016 assessed return to work delay and factors associated with return to work in 275 patients with fragility fractures in Canada; 88% had returned to work with an average absenteeism period of 20.5 days. The average duration of presenteeism (presence at work but with reduced productivity due to the fracture) was 2.9 hours in 4 weeks. Another Japanese study found a risk ratio of 4 (p <0.001) to greater absenteeism in patients with several osteoporotic fractures, with no difference found in terms of productivity at work compared to patients with a history of a single fracture or without history of osteoporotic fracture. The female sex, the need for surgical management, the existence of work with the need to carry heavy loads were associated with a prolonged return to work time.
The objective here is to assess the occupational impact of osteoporotic fractures occurring in active patients under 65 years of age, and to look for factors predicting a return to work within 3 months after the fracture.
- Conditions
- Osteoporotic Fractures
- Being tested
- No intervention
- Keywords
- osteoporotic fractures, work, quality of life
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
All patients treated between 01/01/2017 and 12/31/2018 in the Fracture sector will be screened through the computerized medical file. For patients who meet all the eligibility criteria, the information note, study questionnaire and a stamped envelope will be sent to them by post. Without feedback from him within 30 days of this submission, the patient is considered not to have objected to the study. The patient's information as well as his non-objection will be recorded in his medical file.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the consequences of osteoporotic fractures on the rate of return to work at 3 months of active patients under 65 years of age
Rate of patients returning to work 3 months after fracture
Measured: Month 3
Secondary outcomes (3)
To assess the consequences of osteoporotic fractures on the average return to work time of active patients under 65 years of age.
Average time to return to work
Measured: Day 1
Evaluate the consequences of osteoporotic fractures on quality of life in active patients under 65
Quality of life Short Form - 36 (SF36 scale)
Measured: Month 3
Define the predictive factors for not returning to work.
Correlation (uni and multivariate regression) between returning to work or not and certain parameters such as personal and professional characteristics
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start26 Apr 2019
- Primary completion15 Jul 2019
- Study completion21 Sep 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès PORTIER, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781556
- Sponsor's protocol ID
- OPTIWORK
- Acronym
- OPTIWORK
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Osteoporotic Fractures on Work: Data From a Fracture Liaisons Service
- ClinicalTrials.gov ID
- NCT04781556
- Acronym / sponsor ID
- OPTIWORK / OPTIWORK
- Conditions
- Osteoporotic Fractures
- Keywords
- osteoporotic fractures, work, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 4 Mar 2021 (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.
Osteoporosis is a bone disease characterized by a decrease in bone density with deterioration of the micro-architecture and the appearance of bone fragility, responsible for an increased risk of fractures. The most common osteoporotic fractures are spinal, wrist and femoral neck fractures. Osteoporosis affects 22.7% of women and 6.9% of men in France. Each year, around 8.9 million fragility fractures are identified worldwide, with an incidence in France in 2017 of 382,000 patients in France in 2017.
The economic impact, the functional consequences and the quality of life of patients with osteoporosis, fracture or not, have been widely described in the literature in recent years. There is indeed a great alteration in the mobility, functional capacities and overall quality of life of these patients, measured by composite scores such as Short Form-36 (SF-36), EuroQol 5 Dimensions (EQ-5D) , the Health-related quality of life (HRQoL), or more specifically for osteoporosis, osteoporososis quality of life questionnaire (OQLQ) or its shortened version OLQ, the osteoporosis assessment questionnaire (OPAQ), the Quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (specific for vertebral fractures), etc.
However, few studies have focused on the repercussions of osteoporotic fractures at work, because this pathology affects more elderly subjects (> 65 years old) and therefore retirees.
Detailed description
New osteoporosis management programs have emerged in recent years, in order to improve the management of this pathology by linking the specialties concerned. Among them, La Filière Fracture (in Anglo-Saxon: Fractures Liaisons Services: FLS) of the Paris Saint-Joseph Hospital Group (GHPSJ), created in 2015, aims to follow up patients consulting the GHPSJ for an osteoporotic fracture of spinal location. , the upper end of the femur or the lower end of the radius.
Since the creation of the sector, 2,486 patients have been recruited; it was found that in 529 of these patients (or 21.3%), the osteoporotic fracture occurred at an age of less than 65 years.
The impact on the work of an osteoporotic fracture has been little studied in the literature: a study focused specifically on fractures of the upper extremity of the femur, and found, in 291 patients under 65 years recruited between 2009 and 2013, a 65% return to work rate at 12 months, or around a third of patients who have not returned to professional activity at one year. A study published in 2016 assessed return to work delay and factors associated with return to work in 275 patients with fragility fractures in Canada; 88% had returned to work with an average absenteeism period of 20.5 days. The average duration of presenteeism (presence at work but with reduced productivity due to the fracture) was 2.9 hours in 4 weeks. Another Japanese study found a risk ratio of 4 (p <0.001) to greater absenteeism in patients with several osteoporotic fractures, with no difference found in terms of productivity at work compared to patients with a history of a single fracture or without history of osteoporotic fracture. The female sex, the need for surgical management, the existence of work with the need to carry heavy loads were associated with a prolonged return to work time.
The objective here is to assess the occupational impact of osteoporotic fractures occurring in active patients under 65 years of age, and to look for factors predicting a return to work within 3 months after the fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated between 01/01/2017 and 31/12/2018 in the Fracture sector will be screened through the computerized medical file
Key inclusion criteria (4 listed)
- Patients aged 18 to 65 at the time of the fracture
- French-speaking patient
- Patients treated in the Fracture Line between January 1, 2017 and December 31, 2018 for osteoporotic fracture
- Professionally active patients at the time of the fracture
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
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 |
|---|---|---|
| No interventionAll patients treated between 01/01/2017 and 12/31/2018 in the Fracture sector will be screened through the computerized medical file. For patients who meet all the eligibility criteria, the information note, study questionnaire and a stamped envelope will be sent to them by post. Without feedback from him within 30 days of this submission, the patient is considered not to have objected to the study. The patient's information as well as his non-objection will be recorded in his medical file. | Other | – |
Primary outcome
To assess the consequences of osteoporotic fractures on the rate of return to work at 3 months of active patients under 65 years of age
Time frame: Month 3
Rate of patients returning to work 3 months after fracture
3 secondary outcomes
To assess the consequences of osteoporotic fractures on the average return to work time of active patients under 65 years of age.
Time frame: Day 1
Evaluate the consequences of osteoporotic fractures on quality of life in active patients under 65
Time frame: Month 3
Define the predictive factors for not returning to work.
Time frame: Day 1
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 9 Mar 2021.
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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.
Agnès PORTIER principal investigator
Fondation Hôpital Saint-Joseph
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 Osteoporotic Fractures, run by Fondation Hôpital Saint-Joseph 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 4 inclusion and 4 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 9 Mar 2021. 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?
To assess the consequences of osteoporotic fractures on the rate of return to work at 3 months of active patients under 65 years of age (time frame: Month 3). 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 9 Mar 2021.