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Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture (OPTIVERT)

Primary Purpose

Osteoporotic Fractures

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Life quality evaluation
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporotic Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe Hospitalier Paris Saint Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Life quality evaluation

Arm Description

Patients consulting the Emergency Department (SAU) or the rheumatology department of the GHPSJ (referred by a colleague orthopaedic surgeon, rheumatologist, radiologist or other) for a recent symptomatic osteoporotic dorsal or lumbar vertebral fracture, are called for a rheumatology consultation, vertebral fracture consultation. Patients consulting in the rheumatology department during a spinal fracture consultation at the GHPSJ as well as patients hospitalized in the rheumatology department at the GHPSJ are selected consecutively. - Arm 1 (intervention): two additional consultations with the rheumatology

Outcomes

Primary Outcome Measures

Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41)
Quality of life questionnaires (QUALEFFO-41)

Secondary Outcome Measures

Assess pain related to vertebral fracture at D0, M12 and M24 after diagnosis: Analogical visual scale
Analogical visual scale on the pain and taking painkillers (yes/no)
Assess life quality: Quality of life questionnaires (QUALEFFO-41)
Quality of life questionnaires (QUALEFFO-41)
Measurement of the walking perimeter
the maximum distance that the person can travel without stopping (in meters)
Number of new osteoporotic fractures (vertebral or nonvertebral)
Fractures that have been confirmed by an imaging examination (X-ray, +- MRI or CT)
Number of new fall(s)
Number of hospitalizations for all causes
Spinal statics
Height in centimeters
Management of osteoporosis
prescription completed (yes/no) antiosteoporotic treatment taken (yes/no)
Analogical visual scale of patient satisfaction
(scale of 0 to 10) following the information meeting with a nurse on osteoporosis

Full Information

First Posted
May 27, 2019
Last Updated
October 4, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03967704
Brief Title
Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
Acronym
OPTIVERT
Official Title
Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
October 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Fractures

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Life quality evaluation
Arm Type
Experimental
Arm Description
Patients consulting the Emergency Department (SAU) or the rheumatology department of the GHPSJ (referred by a colleague orthopaedic surgeon, rheumatologist, radiologist or other) for a recent symptomatic osteoporotic dorsal or lumbar vertebral fracture, are called for a rheumatology consultation, vertebral fracture consultation. Patients consulting in the rheumatology department during a spinal fracture consultation at the GHPSJ as well as patients hospitalized in the rheumatology department at the GHPSJ are selected consecutively. - Arm 1 (intervention): two additional consultations with the rheumatology
Intervention Type
Procedure
Intervention Name(s)
Life quality evaluation
Intervention Description
As part of this research, 2 additional consultations at 12 months and 24 months will be carried out by one of the rheumatologists in the department. At the consultation 12 months after his inclusion, the patient will have a clinical examination, a quality of life questionnaire to complete and additional images (x-rays). For the 24-month consultation, the patient will have a clinical examination, a quality of life questionnaire to complete and the patient may have an additional X-ray of the spine if there is height loss > 2 cm and/or pain.
Primary Outcome Measure Information:
Title
Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41)
Description
Quality of life questionnaires (QUALEFFO-41)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Assess pain related to vertebral fracture at D0, M12 and M24 after diagnosis: Analogical visual scale
Description
Analogical visual scale on the pain and taking painkillers (yes/no)
Time Frame
Day 0 - 1 year - 2 years
Title
Assess life quality: Quality of life questionnaires (QUALEFFO-41)
Description
Quality of life questionnaires (QUALEFFO-41)
Time Frame
2 years
Title
Measurement of the walking perimeter
Description
the maximum distance that the person can travel without stopping (in meters)
Time Frame
Day 0 - 1 year - 2 years
Title
Number of new osteoporotic fractures (vertebral or nonvertebral)
Description
Fractures that have been confirmed by an imaging examination (X-ray, +- MRI or CT)
Time Frame
1 year - 2 years
Title
Number of new fall(s)
Time Frame
1 year - 2 years
Title
Number of hospitalizations for all causes
Time Frame
1 year - 2 years
Title
Spinal statics
Description
Height in centimeters
Time Frame
1 year - 2 years
Title
Management of osteoporosis
Description
prescription completed (yes/no) antiosteoporotic treatment taken (yes/no)
Time Frame
1 year - 2 years
Title
Analogical visual scale of patient satisfaction
Description
(scale of 0 to 10) following the information meeting with a nurse on osteoporosis
Time Frame
1 year - 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnès PORTIER, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28168409
Citation
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Results Reference
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24100705
Citation
Venmans A, Lohle PN, van Rooij WJ. Pain course in conservatively treated patients with back pain and a VCF on the spine radiograph (VERTOS III). Skeletal Radiol. 2014 Jan;43(1):13-8. doi: 10.1007/s00256-013-1729-x. Epub 2013 Oct 8.
Results Reference
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PubMed Identifier
28955695
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture

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