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Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture (OPTIVERT)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoporotic Fractures | Procedure: Life quality evaluation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture |
| Actual Study Start Date : | January 8, 2019 |
| Estimated Primary Completion Date : | January 8, 2021 |
| Estimated Study Completion Date : | July 16, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Life quality evaluation
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 |
Procedure: Life quality evaluation
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.
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- Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41) [ Time Frame: 1 year ]Quality of life questionnaires (QUALEFFO-41)
- Assess pain related to vertebral fracture at D0, M12 and M24 after diagnosis: Analogical visual scale [ Time Frame: Day 0 - 1 year - 2 years ]Analogical visual scale on the pain and taking painkillers (yes/no)
- Assess life quality: Quality of life questionnaires (QUALEFFO-41) [ Time Frame: 2 years ]Quality of life questionnaires (QUALEFFO-41)
- Measurement of the walking perimeter [ Time Frame: Day 0 - 1 year - 2 years ]the maximum distance that the person can travel without stopping (in meters)
- Number of new osteoporotic fractures (vertebral or nonvertebral) [ Time Frame: 1 year - 2 years ]Fractures that have been confirmed by an imaging examination (X-ray, +- MRI or CT)
- Number of new fall(s) [ Time Frame: 1 year - 2 years ]
- Number of hospitalizations for all causes [ Time Frame: 1 year - 2 years ]
- Spinal statics [ Time Frame: 1 year - 2 years ]Height in centimeters
- Management of osteoporosis [ Time Frame: 1 year - 2 years ]prescription completed (yes/no) antiosteoporotic treatment taken (yes/no)
- Analogical visual scale of patient satisfaction [ Time Frame: 1 year - 2 years ](scale of 0 to 10) following the information meeting with a nurse on osteoporosis
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Agnès PORTIER, MD | 01 44 12 69 56 ext +33 | aporter@hpsj.fr | |
| Contact: Gérald RAJZBAUM, MD | 01 44 12 78 06 ext + 33 | grajzbaum@hpsj.fr |
| France | |
| Groupe Hospitalier Paris Saint Joseph | Recruiting |
| Paris, Ile-de-France, France, 75014 | |
| Contact: BEAUSSIER Hélène, PhD, PharmD +33 1 44 12 70 38 hbeaussier@hpsj.fr | |
| Contact: CRC +33 1 44 12 70 33 crc@hpsj.fr | |
| Principal Investigator: | Agnès PORTIER, MD | Groupe Hospitalier Paris Saint Joseph |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 27, 2019 | ||||||||
| First Posted Date ICMJE | May 30, 2019 | ||||||||
| Last Update Posted Date | March 9, 2020 | ||||||||
| Actual Study Start Date ICMJE | January 8, 2019 | ||||||||
| Estimated Primary Completion Date | January 8, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41) [ Time Frame: 1 year ] Quality of life questionnaires (QUALEFFO-41)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture | ||||||||
| Official Title ICMJE | Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture | ||||||||
| 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. |
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| Detailed Description |
A. Particularities of OVF management
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.
|
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE | Osteoporotic Fractures | ||||||||
| Intervention ICMJE | Procedure: Life quality evaluation
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.
|
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| Study Arms ICMJE | Experimental: Life quality evaluation
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: Procedure: Life quality evaluation
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
100 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 16, 2023 | ||||||||
| Estimated Primary Completion Date | January 8, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Symptomatic is defined as spinal pain existence in relation to the vertebral fracture, not attributable to any cause other than the fracture.
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03967704 | ||||||||
| Other Study ID Numbers ICMJE | OPTIVERT | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Groupe Hospitalier Paris Saint Joseph | ||||||||
| Study Sponsor ICMJE | Groupe Hospitalier Paris Saint Joseph | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Groupe Hospitalier Paris Saint Joseph | ||||||||
| Verification Date | March 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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