Long-Term study aims to unlock secrets of brittle bone disease
NCT ID NCT00001594
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 8 times
Summary
This study followed 88 children and young adults with types III and IV osteogenesis imperfecta (brittle bone disease) to track how the condition changes over time. Researchers measured bone density, lung and heart function, hearing, and movement abilities. The goal was to better understand the disease's natural history and improve monitoring and care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors better predict and manage complications of osteogenesis imperfecta, improving care and quality of life.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly test any new therapy, so it cannot lead to a cure or immediate treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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88 people
The number who actually took part.
- Started
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Jan 1997
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Children will be recruited from the United States. This recruitment will be accomplished by our contacts with the Osteogenesis Imperfecta Foundation, parent-to-parent communication, and outside referrals from other health care providers
- Ages
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Up to 10 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Children will be recruited from the United States. This recruitment will be accomplished by our contacts with the Osteogenesis Imperfecta Foundation, parent-to-parent communication, and outside referrals from other health care providers. There are no exclusionary criteria related to race or gender for this protocol. Children enrolled in this study will be limited to those with Sillence Types III and IV OI, as determined by clinical and genetic criteria. Patients age birth to 10 years at enrollment will be considered for this protocol. Children who have not had skin biopsy done for collagen analysis at another facility are preferred for participation in this study. However, previous skin biopsy at another facility will not preclude participation in this protocol. EXCLUSION CRITERIA: Children who can be expected to attain at least some degree of ambulatory skill or have high potential for achieving independent locomotion with assistive technology. Children who are clinically too severe to benefit from this program are defined by the following criteria: 1. The ratio of head circumference age (the age for which the child's head or body size falls at the 50th percentile) to body length age (the age for which the child's length falls at the 50th percentile) is 7:1 or greater; 2. Children who are 24 months of age, and who are unable to sit unsupported for 60 seconds and are unable to demonstrate the ability to prop themselves on upper extremities in the prone position; 3. Children who have other significant medical problems, especially severe cardiopulmonary problems, which have an impact on their physical development. Compliance with the visit schedule, maintenance of the physical therapy program, and completion of the measurement tools are central to our analysis of the outcomes of this study. Failure to comply with these conditions will constitute exclusion criteria.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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