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

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ClinicalTrials.gov Identifier: NCT00131469
Recruitment Status : Completed
First Posted : August 18, 2005
Last Update Posted : November 1, 2013
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Drug: Teriparatide (FORTEO) Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI)
Study Start Date : June 2005
Primary Completion Date : January 2011
Study Completion Date : January 2011

Arms and Interventions

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 Name: FORTEO
Placebo Comparator: Placebo
Daily SQ placebo for 18 months

Outcome Measures

Primary Outcome Measures :
  1. The primary aim of this study is to assess whether there will be a significant increase in spine bone mineral density (BMD) as a result from Forteo therapy. [ Time Frame: 01/01/11 ]

Secondary Outcome Measures :
  1. Secondary aims are to determine if Forteo therapy will increase hip and radial BMD, increase estimated vertebral strength, and decrease the rate of fragility fractures in individuals affected with OI. [ Time Frame: 01/01/11 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131469

United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
United States, Texas
Baylor College of Medicine, Department of Molecular and Human Gentics
Houston, Texas, United States, 77030
Sponsors and Collaborators
Oregon Health and Science University
Eli Lilly and Company
Osteogenesis Imperfecta Foundation
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Orwoll, MD, Professor Of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00131469     History of Changes
Other Study ID Numbers: IBMD-OI
UL1RR024140 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2005    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Eric Orwoll, MD, Oregon Health and Science University:
Osteogenesis Imperfecta
Brittle Bone Disease
Fragility Fractures

Additional relevant MeSH terms:
Osteogenesis Imperfecta
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs