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Sponsors and Collaborators: |
Oregon Health and Science University Eli Lilly and Company Osteogenesis Imperfecta Foundation National Institutes of Health (NIH) |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00131469 |
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). There is no established medical therapy for adults with the disorder. Virtually all of the studies reviewing potential treatments for OI have evaluated the effects of medications only on children with OI. There is no data concerning the usefulness of parathyroid hormone therapy in OI. The working hypothesis is that adults affected with OI who are treated with FORTEO will experience increased spine and hip bone mineral density and an increase in bone width and thickness. Adult patients with OI will be enrolled in this study for 18 months. Half the patients will receive PTH (FORTEO) and the other half placebo (no active drug). Blood, urine, and bone density tests will be done during the study for safety monitoring.
There are three clinic sites for this study; Oregon Health & Science University (Portland, OR), Kennedy Krieger Institute (Johns Hopkins University, Baltimore, MD), and Baylor College of Medicine (Houston, TX).
Condition | Intervention | Phase |
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Osteogenesis Imperfecta |
Drug: Teriparatide (FORTEO) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Structure in Adults Affected With Osteogenesis Imperfecta (OI) |
Estimated Enrollment: | 90 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | September 2009 |
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, the major component of bones, characterized by multiple fractures and fragile bones. OI affects approximately 1 to 2 out of every 10,000 individuals of all racial and ethnic origins. There is no cure for osteogenesis imperfecta and there is no established medical therapy for adults with the disorder. Virtually all of the studies reviewing potential treatments for OI have evaluated the effects of medications only on children with OI. Early studies included the use of anabolic steroids, sodium fluoride and testosterone, Vitamins C and D, and calcitonin 1, 4 with minimal or no improvement in bone formation. There is no data concerning the usefulness of parathyroid hormone therapy in OI. Daily low-dose administration of parathyroid hormone (PTH) produces a bone building effect on bone. An effective bone building therapy available for the treatment of adult patients with OI would be an extremely attractive and valuable asset not only to the affected patients but also to the medical community at large.
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 width and thickness. Although FORTEO is not expected to change the defect in the collagen produced, it is expected to increase the quantity of bone formed and improve bone thickness. Therefore, the researchers hypothesize that overall bone strength will be enhanced in OI and fracture incidence will be reduced. Patients with OI will be enrolled in this study for about 18 months. Half the patients will receive PTH (FORTEO) and the other half placebo (no active drug). Blood, urine, and bone density tests will be done during the study for safety monitoring and to see if the PTH is working. Participants will be recruited through the Bone and Mineral Disease clinics, Pediatrics Clinics, Orthopedic clinics, from families of OI patients, the Osteogenesis Imperfecta Foundation, and the general public. The OI Foundation is very enthusiastic about the study and has agreed to alert their membership concerning it. The study will be conducted at each site’s General Clinical Research Center.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandra L Veith, CCRA | 503 494.5630 | veithsa@ohsu.edu |
United States, Maryland | |
Kennedy Krieger Institute | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Jay Shapiro, MD 443-923-2703 shapiroj@kennedykrieger.org | |
Contact: Kim Pfeifer, RN 443-923-2704 pfeifer@kennedykrieger.org | |
Principal Investigator: Jay Shapiro, MD | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Sandra L Veith, CCRA 503-494-5630 veithsa@ohsu.edu | |
Principal Investigator: Eric S Orwoll, M.D. | |
United States, Texas | |
Baylor College of Medicine, Department of Molecular and Human Gentics | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Branden Lee, MD, PhD | |
Contact: Mary A Mullins, RN 832-822.4263 mullins@bcm.tmc.edu | |
Principal Investigator: Branden Lee, MD, PhD |
Principal Investigator: | Eric S Orwoll, M.D. | Oregon Health and Science University |
Principal Investigator: | Robert Steiner, M.D. | Oregon Health and Science University |
Principal Investigator: | Jay Shapiro, M.D. | Kennedy-Krieger Research Institute |
Principal Investigator: | Branden Lee, M.D., PhD | Balor College of Medicine |
Principal Investigator: | Sandra Veith, CRA | Oregon Health and Science University |
Principal Investigator: | Sven Prevrhal, PhD | University of California at San Francisco |
Principal Investigator: | Peter Byers, M.D. | Universtiy of Washington |
Study ID Numbers: | IBMD-OI |
Study First Received: | August 16, 2005 |
Last Updated: | June 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00131469 |
Health Authority: | United States: Institutional Review Board |
Osteogenesis Imperfecta Brittle Bone Disease Fragility Fractures |
Osteogenesis Imperfecta Osteogenesis imperfecta Collagen Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Teriparatide |
Fractures, Bone Connective Tissue Diseases Bone Diseases, Developmental Osteochondrodysplasias Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |