Osteoporotic FracturesOPTIVERTNCT03967704
Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
A study testing Life quality evaluation in people with Osteoporotic Fractures, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporotic Fractures
- What is being tested?
- Life quality evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2019to 2 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read the detailed description
- 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.
- 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.
- Conditions
- Osteoporotic Fractures
- Being tested
- Life quality evaluation
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life quality evaluationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Life quality evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (9)
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)
Measured: Day 0 - 1 year - 2 years
Assess life quality: Quality of life questionnaires (QUALEFFO-41)
Quality of life questionnaires (QUALEFFO-41)
Measured: 2 years
Measurement of the walking perimeter
the maximum distance that the person can travel without stopping (in meters)
Measured: Day 0 - 1 year - 2 years
Number of new osteoporotic fractures (vertebral or nonvertebral)
Fractures that have been confirmed by an imaging examination (X-ray, +- MRI or CT)
Measured: 1 year - 2 years
Number of new fall(s)
Measured: 1 year - 2 years
Number of hospitalizations for all causes
Measured: 1 year - 2 years
Spinal statics
Height in centimeters
Measured: 1 year - 2 years
Management of osteoporosis
prescription completed (yes/no) antiosteoporotic treatment taken (yes/no)
Measured: 1 year - 2 years
Analogical visual scale of patient satisfaction
(scale of 0 to 10) following the information meeting with a nurse on osteoporosis
Measured: 1 year - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start8 Jan 2019
- Primary completion15 Jan 2022
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès PORTIER, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967704
- Sponsor's protocol ID
- OPTIVERT
- Acronym
- OPTIVERT
- Status last verified
- Oct 2023
- First submitted
- 27 May 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28168409Venmans 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.
PubMed 24100705Jung 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.
PubMed 28955695Lips 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.
PubMed 9102060Lindsay 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.
PubMed 11176842Li 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.
PubMed 26378444Carlier 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.
PubMed 15486209Tsoumakidou 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.
PubMed 28105496Ibrahim 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.
PubMed 28972994Genant 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.
PubMed 8237484
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
- ClinicalTrials.gov ID
- NCT03967704
- Acronym / sponsor ID
- OPTIVERT / OPTIVERT
- Conditions
- Osteoporotic Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Life quality evaluation | Experimental | Procedure: Life quality evaluationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life quality evaluationAs 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. | Procedure or surgery | Life quality evaluation |
Primary outcome
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)
9 secondary outcomes
Assess pain related to vertebral fracture at D0, M12 and M24 after diagnosis: Analogical visual scale
Time frame: Day 0 - 1 year - 2 years
Assess life quality: Quality of life questionnaires (QUALEFFO-41)
Time frame: 2 years
Measurement of the walking perimeter
Time frame: Day 0 - 1 year - 2 years
Number of new osteoporotic fractures (vertebral or nonvertebral)
Time frame: 1 year - 2 years
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
Management of osteoporosis
Time frame: 1 year - 2 years
Analogical visual scale of patient satisfaction
Time frame: 1 year - 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Results publication: PubMed 28168409Ballane 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.
- Results publication: PubMed 24100705Venmans 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 publication: PubMed 28955695Jung 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.
- Results publication: PubMed 9102060Lips 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.
- Results publication: PubMed 11176842Lindsay 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.
- Results publication: PubMed 26378444Li 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.
- Results publication: PubMed 15486209Carlier 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.
- Results publication: PubMed 28105496Tsoumakidou 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.
- Results publication: PubMed 28972994Ibrahim 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.
- Results publication: PubMed 8237484Genant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnès PORTIER, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life quality evaluation in people with Osteoporotic Fractures, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967704, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.