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

NCT00131469 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2019-04-24

Study results available
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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).

Conditions

Interventions

DRUG

Teriparatide (FORTEO)

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

DRUG

Placebos

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Osteogenesis Imperfecta Foundation

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Eric S Orwoll, M.D. · Oregon Health and Science University

  • Jay Shapiro, M.D. · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  • Brendan Lee, M.D., PhD · Balor College of Medicine

  • Sandra Veith, CRA · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00131469 on ClinicalTrials.gov