Understanding lung health in people with Osteogenesis Imperfecta
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
This study looks at how Osteogenesis Imperfecta affects lung health in people with the condition to see if there are differences based on sex.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT05317637 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess cardiopulmonary outcomes in individuals with Osteogenesis Imperfecta (OI), a genetic disorder affecting bone and connective tissue. Participants will undergo a single study visit where their medical history, physical evaluations, and diagnostic studies will be collected to understand the impact of OI on lung function. The study will enroll 18 participants of all OI types, focusing on potential differences in outcomes based on sex. The findings will help validate the presence of bronchial wall thickening in OI patients and explore the relationship between OI and respiratory health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Osteogenesis Imperfecta, regardless of its type.
Not a fit: Patients with recent respiratory illnesses or other skeletal dysplasias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of respiratory complications in patients with Osteogenesis Imperfecta.
How similar studies have performed: While there is limited research specifically on cardiopulmonary outcomes in OI, studies on related connective tissue disorders have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals who are able to give informed consent or have a legally authorized representative capable of giving consent on the subject's behalf * Individuals ages 18 and older of all races and sexes * Individuals who have been diagnosed with OI clinically and/or genetically Exclusion Criteria: * Individuals diagnosed with respiratory illness within 6 weeks of enrollment or undergoing diagnostic studies for an active illness. * Individuals with other skeletal dysplasia or genetic diagnosis * Individuals diagnosed with cardiopulmonary comorbidities that affect lung compliance
Where this trial is running
Los Angeles, California and 2 other locations
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- Kennedy Krieger Institute / Hugo W. Moser Research Institute — Baltimore, Maryland, United States (Recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Vernon Sutton, MD — Baylor College of Medicine
- Study coordinator: Dianne Nguyen
- Email: diannen@bcm.edu
- Phone: 713.798.6694
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.