Osteogenesis ImperfectaNCT02934451
Dental Malocclusion and Craniofacial Development in OI
An observational study of Osteogenesis Imperfecta, run by Baylor College of Medicine at 3 sites in 2 countries.
Trial summary
Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily. Individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss and pain and difficulty getting around. Read more about this study
- Who is it for?
- Ages 10 to 100 years
- Conditions the study is for
- Osteogenesis Imperfecta
- How many people
- 75 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2016to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with Severe OI
Who may be able to join
- Males and females with Clinical diagnosis of OI other than OI type I
- Individuals 10 years or older
- Participant of the Brittle Bone Disease (BBD) Longitudinal Study (7701)
Who cannot join
- Individuals who cannot be correctly positioned for valid radiographic analysis (e.g., due to severe scoliosis or short neck secondary to basilar invagination)
- Women who are pregnant
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90095
About this study
Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily. Individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss and pain and difficulty getting around. People with moderate to severe OI may also be diagnosed with dentinogenesis imperfecta (DI). DI is characterized by grey or brown teeth that may chip and wear down and break easily. People with DI may also have skull and neck defects. These patients may have severe teeth misalignment resulting in clinically significant chewing problems. Teeth misalignment in OI is very hard to treat because of the quality and quantity of bone. The overall goal of this study is to improve dental health to improve the quality of life of people with OI.
Read the detailed description
Investigators will look at dental health in people with OI and will describe teeth misalignment and head and neck defects in individuals with moderate to severe Osteogenesis Imperfecta (OI).
Investigators will look at results from the Longitudinal study of OI to complete the study evaluations. Several x-rays will be performed for this study. Participants will have a 3D scan of the mouth and a Cone Beam CT scan of the jaw at a baseline visit and at 3 years after the baseline visit. These study visits can be at the same time as the Longitudinal Study of OI study visits.
- Conditions
- Osteogenesis Imperfecta
- Medical subject headings
- Osteogenesis Imperfecta
What is being measured
The primary outcome is the main question the study is designed to answer.
Teeth Misalignment
Measure teeth misalignment in individuals with moderate to severe OI using scans of the teeth.
Measured: 5 years
Secondary outcomes (1)
Neck Defects
Determine neck defects in individuals with moderate to severe OI using scans of the neck and jaw.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children, Hospital for Special Surgery, New York, University of Nebraska, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Children's National Research Institute, University of California, Los Angeles, Oregon Health and Science University
- Responsible party
- Principal investigator, Brendan Lee, Baylor College of Medicine
- Investigators
- Jean-Marc Retrouvey, D.M.D., Study chair, McGill UniversityReid Sutton, M.D., Study chair, Baylor College of MedicineFrank Rauch, M.D., Study chair, Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934451
- Sponsor's protocol ID
- H38629
- Status last verified
- Jan 2025
- First submitted
- 12 Oct 2016
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The clinical information collected for this study will be stored in a computer database at the Data Management and Coordinating Center at the University of South Florida in Tampa, FL and also sent to a Federal data repository. A data repository provides a way for researchers to store the information collected during the research study for future research studies. The data management center uses several layers of protection for the clinical data stored in its computer database. It meets all of the local and federal security requirements for research datacenters. Information is stored only using a study identification number. Only the investigators and the study staff who collect and enter study data will have access to the key which links the identification number to the participant.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Malocclusion and Craniofacial Development in OI
- ClinicalTrials.gov ID
- NCT02934451
- Acronym / sponsor ID
- H38629
- Conditions
- Osteogenesis Imperfecta
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children, Hospital for Special Surgery, New York, University of Nebraska, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Children's National Research Institute, University of California, Los Angeles, Oregon Health and Science University
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- 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 inherited disorder that causes bones to break easily. Individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss and pain and difficulty getting around. People with moderate to severe OI may also be diagnosed with dentinogenesis imperfecta (DI). DI is characterized by grey or brown teeth that may chip and wear down and break easily. People with DI may also have skull and neck defects. These patients may have severe teeth misalignment resulting in clinically significant chewing problems. Teeth misalignment in OI is very hard to treat because of the quality and quantity of bone. The overall goal of this study is to improve dental health to improve the quality of life of people with OI.
Detailed description
Investigators will look at dental health in people with OI and will describe teeth misalignment and head and neck defects in individuals with moderate to severe Osteogenesis Imperfecta (OI).
Investigators will look at results from the Longitudinal study of OI to complete the study evaluations. Several x-rays will be performed for this study. Participants will have a 3D scan of the mouth and a Cone Beam CT scan of the jaw at a baseline visit and at 3 years after the baseline visit. These study visits can be at the same time as the Longitudinal Study of OI study visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with Severe OI
Key inclusion criteria (3 listed)
- Males and females with Clinical diagnosis of OI other than OI type I
- Individuals 10 years or older
- Participant of the Brittle Bone Disease (BBD) Longitudinal Study (7701)
Key exclusion criteria (2 listed)
- Individuals who cannot be correctly positioned for valid radiographic analysis (e.g., due to severe scoliosis or short neck secondary to basilar invagination)
- Women who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Teeth Misalignment
Time frame: 5 years
Measure teeth misalignment in individuals with moderate to severe OI using scans of the teeth.
1 secondary outcome
Neck Defects
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. The clinical information collected for this study will be stored in a computer database at the Data Management and Coordinating Center at the University of South Florida in Tampa, FL and also sent to a Federal data repository. A data repository provides a way for researchers to store the information collected during the research study for future research studies. The data management center uses several layers of protection for the clinical data stored in its computer database. It meets all of the local and federal security requirements for research datacenters. Information is stored only using a study identification number. Only the investigators and the study staff who collect and enter study data will have access to the key which links the identification number to the participant.
Related trials for Osteogenesis Imperfecta
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
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Setrusumab vs Placebo for Osteogenesis Imperfecta
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Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
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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.
Jean-Marc Retrouvey, D.M.D. study chair
McGill University
Reid Sutton, M.D. study chair
Baylor College of Medicine
Frank Rauch, M.D. study chair
Shriners Hospital for Children
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteogenesis Imperfecta, run by Baylor College of Medicine at 3 sites in 2 countries.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teeth Misalignment (time frame: 5 years). 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 27 Jan 2026.