Status:
COMPLETED
Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Eli Lilly and Company
Osteogenesis Imperfecta Foundation
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00131469
Start Date
June 1 2005
End Date
January 1 2011
Last Update
April 24 2019
Active Locations (3)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
2
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
3
Baylor College of Medicine, Department of Molecular and Human Gentics
Houston, Texas, United States, 77030