Clinical trial NCT03967704: Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
Official title: Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporotic Fractures
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The management of osteoporotic fractures has recently changed with the emergence of new programs dedicated to the diagnosis and treatment of osteoporosis. For example, the Fracture Network of the Paris Saint-Joseph Hospital Group, created in 2015, identifies and ensures the care of patients who have consulted emergency rooms for osteoporotic fractures. Within this sector, the vertebral fracture (VF) appears to be the most frequent (22.4%) ahead of other fracture sites, confirming the results of other studies that consider VF as a real public health problem.

Osteoporotic vertebral fractures (OVF) have certain specificities compared to other osteoporotic fractures, encouraging particular interest.

Detailed description: A. Particularities of OVF management

* Pain intensity caused by OVF justifies specific analgesic management. Analgesic management is sometimes complicated by co-morbidities and patients age, with poor analgesics tolerance, in particular opioids.
* OVF is responsible for a change in patients' quality of life, often with a loss of autonomy.
* VF is considered as severe fracture that warrants anti-osteoporotic drug therapy (if osteoporotic origin has been confirmed), in order to avoid risk of a new osteoporotic fracture.
* Progressive profil of pain associated with OVF and importance vertebral extent collapse may justify the use of specific "vertebral augmentation" procedures on vertebra, such as cementoplasty or kyphoplasty. These interventions are aimed at disappearance / reduction of pain related to OVF, improvement of life quality or correction or elimination of a static spinal disorder related to fracture.

B. Current rheumatology OVF management at the GHPSJ Patients management with OVF can be either outpatient or inpatient, depending on the extent of pain, fracture context, and co-morbidities.

- Rheumatology department of the GHPSJ has set up an outpatient patient path dedicated to osteoporotic vertebral fracture, making it possible to optimize patients concerned management. This route has follow characteristics : Patients with OVF are seen by rheumatologist during a consultation dedicated to OVF (Vertebral Fracture Consultation), and benefit the same day from spinal radiographs, bone densitometry and a biological assessment of fragile osteopathy on the GHPSJ site. During consultation, fracture history, risk factors for falls, bone history, an assessment of the patient's pain, functional abilities and life quality are performed. A spinal orthosis can be made if necessary.

Then patients are seen again 15 days later by the same rheumatologist with all results of the assessment During this 2nd consultation, depending on results of the additional examinations and patient's clinical progress, analgesic treatment is adapted. In addition, anti-osteoporotic treatment may be prescribed.

* For patients with OVF requiring hospital management in the rheumatology department, additional examinations are also carried out with the same anamnestic and clinical elements as for the above-mentioned outpatient management. Nevertheless, intensity of pain may initially prevent certain additional examinations, such as bone densitometry, from being carried out, which in this case are deferred until the patient's state of health allows them.
* During outpatient or inpatient journey, depending on results of additional examinations and patient's clinical progress, intervention therapy can be decided and carried out as soon as possible (cementoplasty). Patients for whom cementoplasty is performed are hyperalgia patients with rapid loss of autonomy due to vertebral fracture and a general condition compatible with general anesthesia. Following cementoplasty, patients are seen again in consultation for 1 month for a clinical examination.

Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Patient consulting or hospitalized in the rheumatology department at the GHPSJ for recent and symptomatic osteoporotic spinal or lumbar fracture Recentness is defined either by anamnestic event existence (example: fall) to date the fracture less than 4 months old, or by MRI or CT signs existence of attesting to recent nature of the fracture: hypersignal T2 stir \& hyposignal T1 on MRI, presence of a cleft on the CT, on imaging less than 4 months old.

Symptomatic is defined as spinal pain existence in relation to the vertebral fracture, not attributable to any cause other than the fracture.

* Patient affiliated to a health insurance plan
* Patient capable of giving free, informed and express consent

Exclusion Criteria:

* Patient with fractures occurring on metastatic spine
* Patient with unstable VF, requiring rapid orthopedic management
* Patient with a history of cementoplasty on dorsal or lumbar spine
* Patients transferred to another hospital after transition to SAU
* Homeless patient
* Patient not residing in Ile-de-France
* Patient who is bedridden or has one or more severe co-morbidity(s) that puts fractured osteoporosis in background
* Patient deprived of liberty
* Patient under guardianship or curators

Primary outcomes:
measure: Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41)
timeFrame: 1 year
Secondary outcomes:
measure: Assess pain related to vertebral fracture at D0, M12 and M24 after diagnosis: Analogical visual scale
timeFrame: Day 0 - 1 year - 2 years
measure: Assess life quality: Quality of life questionnaires (QUALEFFO-41)
timeFrame: 2 years
measure: Measurement of the walking perimeter
timeFrame: Day 0 - 1 year - 2 years
measure: Number of new osteoporotic fractures (vertebral or nonvertebral)
timeFrame: 1 year - 2 years
measure: Number of new fall(s)
timeFrame: 1 year - 2 years
measure: Number of hospitalizations for all causes
timeFrame: 1 year - 2 years
measure: Spinal statics
timeFrame: 1 year - 2 years
measure: Management of osteoporosis
timeFrame: 1 year - 2 years
measure: Analogical visual scale of patient satisfaction
timeFrame: 1 year - 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Agnès PORTIER, MD
role: PRINCIPAL_INVESTIGATOR
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