Phase 4
N=78
Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
Osteogenesis Imperfecta
Bottom Line
View on ClinicalTrials.gov: NCT00131469 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Spine Bone Mineral Density (BMD) — 6.1; 2.8 percentage of change in g/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Teriparatide (FORTEO) (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spine Bone Mineral Density (BMD) |
6.1; 2.8 | — |
| SECONDARY Total Hip BMD |
2.6; -2.4 | — |
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).
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00131469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.