Study of Osteogenesis Imperfecta Tendon

Osteogenesis Imperfecta Clinical Trial

— SOIT  

Official title:

Study of Osteogenesis Imperfecta Tendon and Ligament: Retrospective and Prospective Assessment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065111
• Other study ID #: SOIT
• Status: Recruiting
• Start date: September 13, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2023
• Source: Université Catholique de Louvain
• Contact: Catherine Behets
• Phone: +3227645245
• Email: catherine.behets[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• to have an osteogenesis imperfecta

Exclusion Criteria:

• none, since we want to study different types of osteogenesis imperfecta and consider the effect of age.

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

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.

Locations

Country	Name	City	State
Belgium	Pole de Morphologie	Woluwe-Saint-Lambert	Brussels

Sponsors (4)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Hopital Lariboisière, University Hospital, Lille

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tendon stiffness	Triceps suralis tendon, from zero to infinity, expressed in Newton/mm², a high value indicates a high stiffness	Throughout the entire study, approximately during 22 months
Secondary	Grip strength test	Dynamometer	Throughout the entire study, approximately during 22 months
Secondary	Kinesiophobia	Tampa questionnaire	Throughout the entire study, approximately during 22 months
Secondary	Mobility : walking test	Timed-up and go (if walking is possible for the patient)	Throughout the entire study, approximately during 22 months
Secondary	Quality of life for children	Pediatric Quality of Life Inventory	Throughout the entire study, approximately during 22 months
Secondary	Quality of life for adults	Medical Outcomes Study 36-item Short-Form Health Survey	Throughout the entire study, approximately during 22 months
Secondary	Pain localization and intensity for children	face scale	Throughout the entire study, approximately during 22 months
Secondary	Pain localization and intensity for adults	visual analogue scale	Throughout the entire study, approximately during 22 months

External Links

•   experimental work