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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR024140 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| Osteogenesis Imperfecta Foundation | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Center for Research Resources (NCRR) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide (FORTEO) | Active Comparator | Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months |
|
| Placebo | Placebo Comparator | Daily SQ placebo for 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide (FORTEO) | Drug | Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spine Bone Mineral Density (BMD) | bone density by dual energy xray absorptiometry | baseline and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Hip BMD | bone density by dual energy xray absorptiometry | baseline and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States | ||
| Oregon Health & Science University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24463451 | Derived | 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;124(2):491-8. doi: 10.1172/JCI71101. Epub 2014 Jan 27. |
| Label | URL |
|---|---|
| Osteogenesis Imperfecta Foundation | View source |
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One participant was formally enrolled but then dropped out before the first study treatment was administered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide (FORTEO) | Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily |
| FG001 | Placebo | Daily SQ placebo for 18 months Placebos |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide (FORTEO) | Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spine Bone Mineral Density (BMD) | bone density by dual energy xray absorptiometry | Posted | Mean | Standard Error | percentage of change in g/cm2 | baseline and 18 months |
|
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriparatide (FORTEO) | Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Orwoll | OHSU | 15034940225 | orwoll@ohsu.edu |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| NIH |
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| Placebos | Drug |
|
| Portland |
| Oregon |
| 97239-3098 |
| United States |
| Baylor College of Medicine, Department of Molecular and Human Gentics | Houston | Texas | 77030 | United States |
| Death |
|
| Lost to Follow-up |
|
| scan not analyzable |
|
Daily SQ placebo for 18 months
Placebos
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Total Hip BMD | bone density by dual energy xray absorptiometry | Posted | Mean | Standard Error | percentage of change in g/cm2 | baseline and 18 months |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Placebo | Daily SQ placebo for 18 months Placebos | 1 | 40 | 0 | 40 | 0 | 40 |
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| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |