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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

August 16, 2005
October 30, 2013
June 2005
January 2011   (final data collection date for primary outcome measure)
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 ]
The primary aim of this study is to assess whether an increase in BMD will result from the use of rhPTH.
Complete list of historical versions of study NCT00131469 on ClinicalTrials.gov Archive Site
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 ]
A secondary aim is to determine if PTH therapy will decrease fragility fractures in individuals affected with OI.
Not Provided
Not Provided
 
Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Osteogenesis Imperfecta
Drug: Teriparatide (FORTEO)
Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
Other Name: FORTEO
  • Active Comparator: Teriparatide (FORTEO)
    Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months
    Intervention: Drug: Teriparatide (FORTEO)
  • Placebo Comparator: Placebo
    Daily SQ placebo for 18 months
Orwoll ES, Shapiro J, Veith S, Wang Y, Lapidus J, Vanek C, Reeder JL, Keaveny TM, Lee DC, Mullins MA, Nagamani SC, Lee B. Evaluation of teriparatide treatment in adults with osteogenesis imperfecta. J Clin Invest. 2014 Feb 3;124(2):491-8. doi: 10.1172/JCI71101. Epub 2014 Jan 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
January 2011
January 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131469
IBMD-OI, UL1RR024140
Yes
Eric Orwoll, MD, Oregon Health and Science University
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
Oregon Health and Science University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP