Bisphosphonate Therapy for Osteogenesis Imperfecta
Osteogenesis Imperfecta, Osteoporosis, Paget Disease of Bone
About this trial
This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring Osteogenesis Imperfecta, Fractures, Pediatric, Osteoporosis, Juvenile Pagets
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Alendronate
Pamidronate
1 mg/kg po qd rounded to nearest 10 or 20 mg dose
3 mg/kg IV q4 months