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NCT00001305 · ClinicalTrials.gov registry record · Phase 3
Growth Hormone Therapy in Osteogenesis Imperfecta
A Phase 3 study of Osteogenesis Imperfecta, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00001305: Completed Phase 3 study of Osteogenesis Imperfecta, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00001305 is a Phase 3 study of Osteogenesis Imperfecta that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 42 participants, below the 158-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001305, a Phase 3 study of Osteogenesis Imperfecta, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent feature of mild to moderate forms of the disease. The reason that children with OI are short is not fully understood. We do know that details such as the number of fractures suffered or the type of OI do not fully explain the short stature of OI. Growth patterns have been defined for children with OI Types I, III, and IV. At about 12 months of age, children with Types III and IV OI demonstrate a predictable plateau of their linear growth rate. Type IV OI children begin to resume a normal growth rate at about age four to five years, but they will not "catch up" to a normal height, as they have "lost" a significant period of growth. The plateau usually continues for children with Type III OI. The reason for this growth plateau is unknown. There have been no studies which evaluate the growth of OI children in this age range. Our previous studies of growth in OI children have begun at age 5 years. We have studied growth in OI children for the past 10 years. Different medications have been tried to both stimulate growth and improve bone density. Some children have responded to growth hormone (their growth rate increased by at least 50%) and some did not. The majority of children who did respond were Type IV. However, we need to carefully treat and study more children to try to determine which children will benefit from growth hormone medication. The Goals of this Study Are: 1. We want to try to find a cause for the growth plateau common in types III and IV OI. Long-term, our goal is to develop a treatment to eliminate this plateau. 2. We want to see how long and how well OI bone will respond to growth stimulation. 3. We hope to find a "predictor" for who will respond to growth hormone and who will not, by measuring your child's endocrine and growth hormone function before receiving any growth hormone treatment. 4. We want to measure the effects of growth stimulation on bone densit
Primary Outcome
The proportion of subjects who met the study criteria of at least 50% increase in growth rate since baseline.
Conditions Studied
Interventions
- DRUG Humatrope
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 1991-11-05 |
| Est. Completion | 2017-05-19 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00001305 record still lists
NCT00001305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 158-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 1 intervention - of which Humatrope is the first listed.
NCT00001305 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001305 about?
NCT00001305 is a clinical study titled "Growth Hormone Therapy in Osteogenesis Imperfecta". Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent feature of mild to moderate forms of the disease. The reason that children with OI are short is not fully understood. We do know that details such as the number of fractures suffered or the type of OI do not ful...
What is the current status of trial NCT00001305?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 1991-11-05. Estimated completion is 2017-05-19.
What conditions does trial NCT00001305 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta.
What interventions are being tested in trial NCT00001305?
The interventions under investigation include: Humatrope (DRUG).
Who is sponsoring clinical trial NCT00001305?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001305 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteogenesis Imperfecta
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001305's enrollment target sits among peer trials
42 11th of 13 higher than 3 of 13 other Osteogenesis Imperfecta trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteogenesis Imperfecta trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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