Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI).

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

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: Eli Lilly and Company; National Center for Research Resources (NCRR); National Institutes of Health (NIH); Osteogenesis Imperfecta Foundation
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

• Previous established diagnosis of Osteogenesis Imperfecta AND

• > 2 previous adult fractures, AND/OR

• BMD at lumbar spine, femoral neck or total hip T score < -2.0

Exclusion Criteria:

• Open epiphyses.

• History of external beam radiation to the skeleton.

• Pagets disease.

• Bone metastases or skeletal malignancies.

• Total lifetime exposure to any antiresorptive medication < 90 days (Primary Inclusion).

• Treatment with any antiresorptive medication 12 months proceeding enrollment - (Secondary Inclusion).

• Women with OI who are pregnant or unwilling to use 1 form of contraception.

• Vitamin D insufficiency (25-hydroxyvitamin D <15ng/ml)