Osteoporosis Clinical Trial
Official title:
Bisphosphonate Therapy for Osteogenesis Imperfecta
Verified date | September 2011 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 21 Years |
Eligibility |
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 - Dentogenesis 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density measured 4 times monthly | 6 years | Yes | |
Primary | fracture rates | 6 years | Yes | |
Secondary | Audiologic effects (annual) | 6 years | Yes | |
Secondary | dental effects (annual) | 6 years | Yes | |
Secondary | pain assessments | 6 years | No | |
Secondary | bone turnover assessments | 6 years | Yes |
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