Osteogenesis Imperfecta Clinical Trial
— OIOfficial title:
A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI)
Verified date | April 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 79 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Kennedy Krieger Institute | Baltimore | Maryland |
United States | Baylor College of Medicine, Department of Molecular and Human Gentics | Houston | Texas |
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | Eli Lilly and Company, National Center for Research Resources (NCRR), National Institutes of Health (NIH), Osteogenesis Imperfecta Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spine Bone Mineral Density (BMD) | bone density by dual energy xray absorptiometry | baseline and 18 months | |
Secondary | Total Hip BMD | bone density by dual energy xray absorptiometry | baseline and 18 months |
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