Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04781556 |
| Other study ID # |
OPTIWORK |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2019 |
| Est. completion date |
September 21, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Groupe Hospitalier Paris Saint Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
