osteogenesis imperfecta
Conditions
Interventions
Eighteen micrograms (2 ml)/kg of alendronate will be infused in 1 hour every 4 weeks. The study duration is 6 months. When the patient'
s BMD reaches to the normal range for age, treatment with alendronate will be finished. When the patient'
s BMD does not reach to the normal range for age, alendronate will be continued for another 6 months.
Sponsors
Tohoku University School of Medicine, Department of Pediatrics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Informed consent obtained from each subject's parent or the subject's legally acceptable representative before any study-related activities. -Patients clinically diagnosed as osteogenesis imperfecta with all the types according to Sillence phenotypes (I - IV).
Exclusion criteria
Exclusion criteria: -Patients with the following diseases which show fracture easily: Juvenile osteoporosis, hypophosphatasia, Ehlers-Danlos syndrome, Osteoporosis-pseudoglioma syndrome, Bruck syndrome. -Patients with osteogenesis imperfecta who falls under any of the following conditions shall be excluded: 1) Patients previously treated with any medical treatment including bisphosphonates 2) Patients with severe renal dysfunction 3) Patients with severe brain complication such as intracranial hemorrhage 4) Patients with congenital heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density (BMD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of fracture | — |
Countries
Japan
Contacts
Public ContactIkuma Fujiwara
Tohoku University School of Medicine Department of Pediatrics
Outcome results
None listed