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

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteogenesis Imperfecta

In brief

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).

Key facts

Study ID

NCT00131469

Run by

Oregon Health and Science University

People needed

79

Starts

2005-06-01

Expected to finish

2011-01-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Baylor College of Medicine, Department of Molecular and Human Gentics — Houston, Texas, United States

Full record on ClinicalTrials.gov

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