Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Osteogenesis Imperfecta Foundation
Information provided by (Responsible Party):
Eric Orwoll, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00131469
First received: August 16, 2005
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Osteogenesis Imperfecta
Drug: Teriparatide (FORTEO)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: June 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131469

Locations
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
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
  More Information

No publications provided by Oregon Health and Science University

Additional 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
Study First Received: August 16, 2005
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014