Impact of Osteoporotic Fractures on Work: Data From a Fracture Liaisons Service

NCT04781556 | Completed

• 1 other identifier: OPTIWORK
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporotic Fractures

Keywords

osteoporotic fractures; work; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Day 1

• Evaluate the consequences of osteoporotic fractures on quality of life in active patients under 65

  Month 3

• Define the predictive factors for not returning to work.

  Day 1

Interventions

No intervention OTHER

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate in the study
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Agnès PORTIER

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: April 26, 2019
• Primary Completion: July 15, 2019
• Study Completion: September 21, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

FR (1)