CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 79 enrolled
Drug / intervention
Teriparatide (FORTEO) +1 moredrug
Likely dose
Teriparatide (FORTEO) 20 mcg subcutaneous injection once dailyAI-extracted
Key inclusion· 3
  • ✓Confirmed diagnosis of Osteogenesis Imperfecta
  • ✓History of >2 adult fractures OR BMD T-score <-2.0 at lumbar spine, femoral neck, or total hip
  • ✓Lifetime antiresorptive medication exposure of ≥90 days
Key exclusion· 6
  • ✕Open epiphyses
  • ✕History of external beam radiation to the skeleton
  • ✕Paget's disease
  • ✕Bone metastases or skeletal malignancies

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00131469
NCT00131469Phase 4Completed
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A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI)

Oregon Health and Science University·interventional·Posted Aug 18, 2005·Updated Apr 24, 2019

In Brief

A Phase 4 clinical trial evaluating Teriparatide (FORTEO) and Placebos for Osteogenesis Imperfecta. Completed, enrolled 79 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteogenesis Imperfecta
CountriesUnited States
CollaboratorsEli Lilly and Company, Osteogenesis Imperfecta Foundation, National Institutes of Health (NIH), National Center for Research Resources (NCRR)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2005
Enrollment StartJun 1, 2005
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 20.9 years ago

Interventions

Teriparatide (FORTEO)drug

Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily

Placebosdrug