Bisphosphonate Therapy for Osteogenesis Imperfecta

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Treatments: Alendronate; Diphosphonates; Pamidronate

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