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

NCT03967704 | Completed

• 1 other identifier: OPTIVERT
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Fractures

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year

Secondary Outcomes (9)

• Assess pain related to vertebral fracture at D0, M12 and M24 after diagnosis: Analogical visual scale

  Day 0 - 1 year - 2 years

• Assess life quality: Quality of life questionnaires (QUALEFFO-41)

  2 years

• Measurement of the walking perimeter

  Day 0 - 1 year - 2 years

• Number of new osteoporotic fractures (vertebral or nonvertebral)

  1 year - 2 years

• Number of new fall(s)

  1 year - 2 years

Study Arms (1)

Life quality evaluation

EXPERIMENTAL

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

Interventions

Life quality evaluation PROCEDURE

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.

Life quality evaluation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

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

Location

Related Publications (10)

• Ballane G, Cauley JA, Luckey MM, El-Hajj Fuleihan G. Worldwide prevalence and incidence of osteoporotic vertebral fractures. Osteoporos Int. 2017 May;28(5):1531-1542. doi: 10.1007/s00198-017-3909-3. Epub 2017 Feb 6.

  PMID: 28168409 RESULT

• 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.

  PMID: 24100705 RESULT

• Jung HJ, Park YS, Seo HY, Lee JC, An KC, Kim JH, Shin BJ, Kang TW, Park SY. Quality of Life in Patients with Osteoporotic Vertebral Compression Fractures. J Bone Metab. 2017 Aug;24(3):187-196. doi: 10.11005/jbm.2017.24.3.187. Epub 2017 Aug 31.

  PMID: 28955695 RESULT

• Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Liberman U, Minne H, Reeve J, Reginster JY, de Vernejoul MC, Wiklund I. Quality of life as outcome in the treatment of osteoporosis: the development of a questionnaire for quality of life by the European Foundation for Osteoporosis. Osteoporos Int. 1997;7(1):36-8. doi: 10.1007/BF01623457.

  PMID: 9102060 RESULT

• Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamou L, Geusens P, Flowers K, Stracke H, Seeman E. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001 Jan 17;285(3):320-3. doi: 10.1001/jama.285.3.320.

  PMID: 11176842 RESULT

• Li L, Ren J, Liu J, Wang H, Wang X, Liu Z, Sun T. Results of Vertebral Augmentation Treatment for Patients of Painful Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Eight Randomized Controlled Trials. PLoS One. 2015 Sep 17;10(9):e0138126. doi: 10.1371/journal.pone.0138126. eCollection 2015.

  PMID: 26378444 RESULT

• Carlier RY, Gordji H, Mompoint DM, Vernhet N, Feydy A, Vallee C. Osteoporotic vertebral collapse: percutaneous vertebroplasty and local kyphosis correction. Radiology. 2004 Dec;233(3):891-8. doi: 10.1148/radiol.2333030400. Epub 2004 Oct 14.

  PMID: 15486209 RESULT

• Tsoumakidou G, Too CW, Koch G, Caudrelier J, Cazzato RL, Garnon J, Gangi A. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017 Mar;40(3):331-342. doi: 10.1007/s00270-017-1574-8. Epub 2017 Jan 19.

  PMID: 28105496 RESULT

• Ibrahim A, Singh DKA, Shahar S. 'Timed Up and Go' test: Age, gender and cognitive impairment stratified normative values of older adults. PLoS One. 2017 Oct 3;12(10):e0185641. doi: 10.1371/journal.pone.0185641. eCollection 2017.

  PMID: 28972994 RESULT

• Genant HK, Wu CY, van Kuijk C, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993 Sep;8(9):1137-48. doi: 10.1002/jbmr.5650080915.

  PMID: 8237484 RESULT

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Agnès PORTIER, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: January 8, 2019
• Primary Completion: January 15, 2022
• Study Completion: October 2, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

FR (1)