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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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16 December 2017 |
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Main ID: |
NCT00159419 |
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Date of registration:
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07/09/2005 |
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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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Bisphosphonate Therapy for Osteogenesis Imperfecta
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Scientific title:
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Bisphosphonate Therapy for Osteogenesis Imperfecta |
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Date of first enrolment:
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August 1999 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00159419 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Linda A DiMeglio, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of OI, as defined by genetic analysis revealing a defect of type I collagen,
OR by bone mineral density (BMD) <2.5 standard deviations (SD) for age plus two of the
following:
- Family history of OI
- Frequent fractures
- Blue sclerae
- Multiple wormian bones on skull x-ray
- Hearing disturbance
- Dentinogenesis imperfecta
- Age between 3 and 21 years at the start of the study period.
- Children must be able to swallow whole tablets
- Parents of children must be able to understand protocol and give informed consent.
Exclusion Criteria:
- Therapy with bisphosphonates during the past 12 months.
- Other "non-traditional" therapy for OI in the last 6 months, such as growth hormone or
anabolic steroids.
- Other chronic diseases besides OI that interfere with bone morphology or
gastrointestinal absorption
Age minimum:
3 Years
Age maximum:
21 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Paget Disease of Bone
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Osteogenesis Imperfecta
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Osteoporosis
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Intervention(s)
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Drug: Alendronate
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Drug: Pamidronate
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Primary Outcome(s)
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Bone Mineral Density
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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