An observational study in Osteogenesis Imperfecta, sponsored by Université Catholique de Louvain. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Université Catholique de Louvain · Observational
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.
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.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's planned enrollment of 130 is above the median of 75 across 23 observational studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →Université Catholique de Louvain is the lead sponsor of 154 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with osteogenesis imperfecta
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: 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.
Tendon stiffness
Triceps suralis tendon, from zero to infinity, expressed in Newton/mm², a high value indicates a high stiffness
Time frame: Throughout the entire study, approximately during 22 months
Grip strength test
Dynamometer
Time frame: Throughout the entire study, approximately during 22 months
Kinesiophobia
Tampa questionnaire
Time frame: Throughout the entire study, approximately during 22 months
Mobility : walking test
Timed-up and go (if walking is possible for the patient)
Time frame: Throughout the entire study, approximately during 22 months
Quality of life for children
Pediatric Quality of Life Inventory
Time frame: Throughout the entire study, approximately during 22 months
Quality of life for adults
Medical Outcomes Study 36-item Short-Form Health Survey
Time frame: Throughout the entire study, approximately during 22 months
Pain localization and intensity for children
face scale
Time frame: Throughout the entire study, approximately during 22 months
Pain localization and intensity for adults
visual analogue scale
Time frame: Throughout the entire study, approximately during 22 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Dec 2024, 15 months after the start.
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