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

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteogenesis Imperfecta

Intervention: Teriparatide (FORTEO) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Eric S Orwoll, M.D., Principal Investigator, Affiliation: Oregon Health and Science University
Jay Shapiro, M.D., Principal Investigator, Affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Brendan Lee, M.D., PhD, Principal Investigator, Affiliation: Balor College of Medicine
Sandra Veith, CRA, Principal Investigator, Affiliation: Oregon Health and Science University

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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)

Locations and Contacts

Kennedy Krieger Institute, Baltimore, Maryland 21205, United States

Oregon Health & Science University, Portland, Oregon 97239-3098, United States

Baylor College of Medicine, Department of Molecular and Human Gentics, Houston, Texas 77030, United States

Additional Information

Starting date: June 2005
Last updated: October 30, 2013

Page last updated: August 20, 2015

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