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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00005901 |
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Date of registration:
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06/06/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pamidronate to Treat Osteogenesis Imperfecta in Children
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Scientific title:
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A Trial of Pamidronate in Children With Osteogenesis Imperfecta |
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Date of first enrolment:
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June 2000 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00005901 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Joan C Marini, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA:
Children enrolled in this study will be limited to those with Sillence types III and IV OI,
as determined by clinical and genetic criteria.
Most of the children who will be included in this study are already enrolled in the
protocols Evaluation and Intervention for Ambulation, Growth, and Basilar Invagination in
Osteogenesis Imperfecta (97-CH-0064) and Growth Hormone Therapy in Osteogenesis Imperfecta
(92-CH-0034).
Screening of candidates will be based on telephone interviews with a parent, and referral
records to include: AP and lateral radiographs of the lower extremities and spine, and
family, developmental, fracture and medical history. An NIH clinical screening evaluation
will be performed for those children who appear to have a history consistent with OI under
protocol 04-CH-0077, Screening of and Diagnosis of Patients with Connective Tissue Disorder
. Patients admitted for this screening visit who are less than four years of age as well as
those older than 4 years of age but not meeting the criteria for inclusion in the growth
hormone protocol, protocol 92-CH-0034, will be considered for enrollment in protocol
97-CH-0064 (Evaluation and Intervention for Ambulation, Growth and Basilar Invagination in
OI), those older than four years who meet the criteria will be considered for co-enrollment
in protocol 92-CH-0034.
The inclusion criteria for protocol 92-CH-0034 are as follows: patients must have a
clinical/biochemical diagnosis of osteogenesis imperfecta types III or IV, height less than
third percentile for age, and radiological evidence that long bone epiphyses have not yet
fused.
Patients are excluded from protocol 92-CH-0034 if they have scoliosis of greater than 40
degrees unless scoliosis has been stable over the past two years, or evidence of severe
basilar invagination.
Patients with previous exposure to bisphosphonates in outside trials will be considered for
participation in this trial.
EXCLUSION CRITERIA:
Inability to comply with the visit schedule, maintenance of the physical therapy program,
and ability to administer and comply with GH injections are central to our analysis of the
outcomes of this study. Failure to comply with these conditions will constitute exclusion
criteria.
Pregnancy.
Patients that have had or will have surgery to place instrumentation in the spine (i.e.
result of spine fusion).
Age minimum:
N/A
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteogenesis Imperfecta
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Intervention(s)
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Drug: Pamidronate (Aredia)
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Primary Outcome(s)
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Change in Bone Mineral Density in Response to Pamidronate
[Time Frame: Baseline vs. 12 months after first dose]
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Change in Bone Mineral Density in Response to Pamidronate
[Time Frame: Baseline vs. 24 months after first dose]
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Change in Bone Mineral Density in Response to Pamidronate
[Time Frame: Baseline vs. 36 months after first dose]
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Change in Bone Mineral Density in Response to Pamidronate
[Time Frame: Baseline vs. 18 months after first dose]
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Change in Bone Mineral Density in Response to Pamidronate
[Time Frame: Baseline vs. 30 months after first dose]
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Change in Bone Mineral Density in Response to Pamidronate
[Time Frame: Baseline vs. 6 months after first dose]
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Secondary ID(s)
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00-CH-0136
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000136
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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