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

April 4, 2019 updated by: Eric Orwoll, MD, Oregon Health and Science University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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). Osteogenesis imperfecta is an inherited disorder of type I collagen, a major component of bones, and is characterized by multiple fractures and deformities. OI affects approximately 1-2 of every 10,000 individuals. Virtually all of the studies of potential treatments for OI have evaluated the effects of medications only on children with OI. There is no cure for osteogenesis imperfecta and there is no established medical therapy for adults with the disorder. There are very limited data concerning the usefulness of parathyroid hormone therapy in OI. An effective anabolic therapy for the treatment of adult patients with OI could be a valuable asset to the affected patients. In this study, the working hypothesis is that individuals affected with OI who are treated with Forteo will experience increased spine and hip bone mineral density and an increase in bone strength. Although Forteo is not expected to change the defect in the collagen produced, but is postulated to increase the quantity of bone formed and improve bone strength.

This will be a placebo controlled, double blinded trial; half the patients will receive Forteo 20 ug/day SQ. Adult patients (age at least 18 yrs) with OI will be enrolled for a treatment duration of 18 months. Blood, urine, and bone density/strength tests will be done during the study to assess efficacy and safety.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine, Department of Molecular and Human Gentics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Teriparatide (FORTEO)
Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months
Drug: Teriparatide (FORTEO)
Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
Other Names:
  • FORTEO
Placebo Comparator: Placebo
Daily SQ placebo for 18 months
Drug: Placebos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spine Bone Mineral Density (BMD)
Time Frame: baseline and 18 months
bone density by dual energy xray absorptiometry
baseline and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Hip BMD
Time Frame: baseline and 18 months
bone density by dual energy xray absorptiometry
baseline and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Eli Lilly and Company
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Osteogenesis Imperfecta Foundation

Investigators

  • Principal Investigator: Eric S Orwoll, M.D., Oregon Health and Science University
  • Principal Investigator: Jay Shapiro, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  • Principal Investigator: Brendan Lee, M.D., PhD, Balor College of Medicine
  • Principal Investigator: Sandra Veith, CRA, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 16, 2005

First Submitted That Met QC Criteria

August 16, 2005

First Posted (Estimate)

August 18, 2005

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBMD-OI
  • UL1RR024140 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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