Osteogenesis ImperfectaSOITNCT06065111
Study of Osteogenesis Imperfecta Tendon
An observational study of Osteogenesis Imperfecta, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Osteogenesis imperfecta (OI) is a rare genetic disease due to a mutation in one of the genes encoding either type I collagen or a protein involved in its synthesis. This leads to bone fragility with fractures and deformities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- study tendon damage in osteogenesis imperfecta patients
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Sep 2023to 1 Jun 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with osteogenesis imperfecta
Who may be able to join
- to have an osteogenesis imperfecta
Who cannot join
- none, since we want to study different types of osteogenesis imperfecta and consider the effect of age.
Trial locations and contacts
1 site in 1 country.
Antoine Chretien contact
Belgium1 site, 1 recruiting
- Recruiting
Pole de Morphologie
Woluwe-Saint-Lambert, Brussels Capital, 1200
Antoine Chretien, PT, +32 2 764 52 27, antoine.chretien@uclouvain.be
About this study
Official title: Study of Osteogenesis Imperfecta Tendon and Ligament: Retrospective and Prospective Assessment.
Osteogenesis imperfecta (OI) is a rare genetic disease due to a mutation in one of the genes encoding either type I collagen or a protein involved in its synthesis. This leads to bone fragility with fractures and deformities. However, other tissues rich in type I collagen can also be affected, such as teeth or vessel walls.
In the literature, several case reports describe tendon ruptures in OI patients, but no original study has really addressed this issue, which is likely to impact the quality of life through a reduction in mobility and pain.
Recent work carried out by the investigators shows an alteration of the osteotendinous unit in the osteogenesis imperfecta mouse (oim), a validated model of the most severe form of OI. Consequently, the project aims to study the damage of tendon and ligament in patients suffering from osteogenesis imperfecta.
Read the detailed description
This project aims to study the damage of tendon and ligament in a cohort of patients suffering from osteogenesis imperfecta. The data collected will be put into perspective with those of our first experimental work on mice. They will also make it possible to complete the specific care of these patients. Indeed, during the anamnesis, particular attention will be paid to the description of tendon-ligament pain in order to propose the most effective treatment for this kind of disorder, mainly in physiotherapy. Prevention work will surely be necessary with patients and caregivers.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- study tendon damage in osteogenesis imperfecta patients
- Keywords
- Osteogenesis Imperfecta
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study tendon damage in osteogenesis imperfecta patientsOther
- To identify and characterize alterations of tendons and ligaments in patients with osteogenesis imperfecta (OI) and to improve clinical management of the disease.
- To analyze interactions of different parameters, such as laxity or administration of bisphosphonates, on the evolution of the disease.
| Study group | Role | What they receive |
|---|---|---|
| study tendon damage in osteogenesis imperfecta patients | The study will be conducted in three centers: Brussels (30 patients, clinique Saint-Luc, Lille (30 patients) and Paris (50 patients). Patients will be recruited regardless of their form of osteogenesis imperfecta. Receives: Other: study tendon damage in osteogenesis imperfecta patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon stiffness
Triceps suralis tendon, from zero to infinity, expressed in Newton/mm², a high value indicates a high stiffness
Measured: Throughout the entire study, approximately during 22 months
Secondary outcomes (7)
Grip strength test
Dynamometer
Measured: Throughout the entire study, approximately during 22 months
Kinesiophobia
Tampa questionnaire
Measured: Throughout the entire study, approximately during 22 months
Mobility : walking test
Timed-up and go (if walking is possible for the patient)
Measured: Throughout the entire study, approximately during 22 months
Quality of life for children
Pediatric Quality of Life Inventory
Measured: Throughout the entire study, approximately during 22 months
Quality of life for adults
Medical Outcomes Study 36-item Short-Form Health Survey
Measured: Throughout the entire study, approximately during 22 months
Pain localization and intensity for children
face scale
Measured: Throughout the entire study, approximately during 22 months
Pain localization and intensity for adults
visual analogue scale
Measured: Throughout the entire study, approximately during 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start13 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Lariboisière, University Hospital, Lille, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Pierre-Louis Docquier, MD, Principal investigator, Cliniques Univresitaires Saint-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065111
- Sponsor's protocol ID
- SOIT
- Acronym
- SOIT
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Osteogenesis Imperfecta Tendon and Ligament: Retrospective and Prospective Assessment.
- ClinicalTrials.gov ID
- NCT06065111
- Acronym / sponsor ID
- SOIT / SOIT
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis Imperfecta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Hopital Lariboisière, University Hospital, Lille, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 3 Oct 2023 (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.
Osteogenesis imperfecta (OI) is a rare genetic disease due to a mutation in one of the genes encoding either type I collagen or a protein involved in its synthesis. This leads to bone fragility with fractures and deformities. However, other tissues rich in type I collagen can also be affected, such as teeth or vessel walls.
In the literature, several case reports describe tendon ruptures in OI patients, but no original study has really addressed this issue, which is likely to impact the quality of life through a reduction in mobility and pain.
Recent work carried out by the investigators shows an alteration of the osteotendinous unit in the osteogenesis imperfecta mouse (oim), a validated model of the most severe form of OI. Consequently, the project aims to study the damage of tendon and ligament in patients suffering from osteogenesis imperfecta.
Detailed description
This project aims to study the damage of tendon and ligament in a cohort of patients suffering from osteogenesis imperfecta. The data collected will be put into perspective with those of our first experimental work on mice. They will also make it possible to complete the specific care of these patients. Indeed, during the anamnesis, particular attention will be paid to the description of tendon-ligament pain in order to propose the most effective treatment for this kind of disorder, mainly in physiotherapy. Prevention work will surely be necessary with patients and caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study tendon damage in osteogenesis imperfecta patients | – | Other: study tendon damage in osteogenesis imperfecta patientsThe study will be conducted in three centers: Brussels (30 patients, clinique Saint-Luc, Lille (30 patients) and Paris (50 patients). Patients will be recruited regardless of their form of osteogenesis imperfecta. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with osteogenesis imperfecta
Key inclusion criteria (1 listed)
- to have an osteogenesis imperfecta
Key exclusion criteria (1 listed)
- none, since we want to study different types of osteogenesis imperfecta and consider the effect of age.
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 |
|---|---|---|
| study tendon damage in osteogenesis imperfecta patients* To identify and characterize alterations of tendons and ligaments in patients with osteogenesis imperfecta (OI) and to improve clinical management of the disease. * To analyze interactions of different parameters, such as laxity or administration of bisphosphonates, on the evolution of the disease. | Other | study tendon damage in osteogenesis imperfecta patients |
Primary outcome
Tendon stiffness
Time frame: Throughout the entire study, approximately during 22 months
Triceps suralis tendon, from zero to infinity, expressed in Newton/mm², a high value indicates a high stiffness
7 secondary outcomes
Grip strength test
Time frame: Throughout the entire study, approximately during 22 months
Kinesiophobia
Time frame: Throughout the entire study, approximately during 22 months
Mobility : walking test
Time frame: Throughout the entire study, approximately during 22 months
Quality of life for children
Time frame: Throughout the entire study, approximately during 22 months
Quality of life for adults
Time frame: Throughout the entire study, approximately during 22 months
Pain localization and intensity for children
Time frame: Throughout the entire study, approximately during 22 months
Pain localization and intensity for adults
Time frame: Throughout the entire study, approximately during 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Antoine Chretien contact
Pierre-Louis Docquier, MD principal investigator
Cliniques Univresitaires Saint-Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteogenesis Imperfecta, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Behets (+3227645245, catherine.behets@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon stiffness (time frame: Throughout the entire study, approximately during 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2023.