NCT07287241 Prospective Observational Cohort Study of Cardiac Structure and Function in Children and Adults With Osteogenesis Imperfecta
| NCT ID | NCT07287241 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Osteogenesis Imperfecta (OI) |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2031-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-06-10 with a primary completion date of 2031-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective observational investigation will examine the incidence and progression of cardiologic findings in individuals with OI across different age groups. Cardiopulmonary complications are recognized as major contributors to morbidity and mortality in adults with OI, although life expectancy has significantly improved in recent years due to medical advancements. By systematically evaluating cardiovascular involvement in this population, the study aims to generate clinically relevant evidence to inform early cardiologic screening strategies and support the development of harmonized and targeted management approaches, ultimately improving clinical practice and the quality of life of individuals living with OI.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of OI according to the modified Sillence classification (Mortier et al., 2019) * All subjects with OI who attend genetic consultations at the clinic affiliated with the Rare Skeletal Diseases Unit of the IRCCS Rizzoli Orthopaedic Institute (IOR) * Willingness to undergo clinical and instrumental assessments at the IOR Exclusion Criteria: * Acute upper and/or lower respiratory tract infections at the time of assessment * Cognitive impairment affecting cooperation and the performance of examinations
Frequently Asked Questions
Who can join the NCT07287241 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 80 Years, studying Osteogenesis Imperfecta (OI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07287241 currently recruiting?
Yes, NCT07287241 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Ortopedico Rizzoli to inquire about joining.
Where is the NCT07287241 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07287241 clinical trial?
NCT07287241 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 40 participants.