Status:
COMPLETED
Bisphosphonate Therapy for Osteogenesis Imperfecta
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Osteogenesis Imperfecta
Osteoporosis
Eligibility:
All Genders
3-21 years
Phase:
PHASE4
Brief Summary
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing...
Detailed Description
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is the major structu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00159419
Start Date
August 1 1999
End Date
August 1 2008
Last Update
June 14 2017
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