Osteogenesis imperfecta
Conditions
Interventions
Pamidronate disodium intervenous for drip use
15mg/day (available up to 30mg/day), 1 infection/day x 3 dats, every 4 months, total 16 months.
Sponsors
Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with osteogenesis imperfecta according to clinical guideline. 2) out patients 3) patinets who filled out the written informed consent related to the participant of this study.
Exclusion criteria
Exclusion criteria: 1) eGFR less than 30 2) patients who have severe renal or hepatic failure. 3) Patients who have allergy against the drug. 4) Patients who are pregnant. 5) Patients who participated to another clinical study within 4 months. 6) Patients who are very poor condition. 7) Patients who have cardiovascular disease (including QTc >500msec). 8) Patinets who are diagnosed as inappropriate for this study including the results of screening test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline of lumbar 1-4 bone mineral density at weak 68. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of both femoral neck and radius bone mineral density. Improvement of bone pain. Improvement of QOL. Rate of adverse event. | — |
Countries
Japan
Contacts
Public ContactHidenori Fukuoka
Kobe University Hospital Diabetes and Endocrinology
Outcome results
None listed