Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131469
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2005-08-16
Brief Title:
Study of Teriparatide FORTEO to Treat Adults With Osteogenesis Imperfecta
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OI
Brief 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
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 10000 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 ugday SQ Adult patients age at least 18 yrs with OI will be enrolled for a treatment duration of 18 months Blood urine and bone densitystrength tests will be done during the study to assess efficacy and safety
This will be a placebo controlled double blinded trial half the patients will receive Forteo 20 ugday SQ Adult patients age at least 18 yrs with OI will be enrolled for a treatment duration of 18 months Blood urine and bone densitystrength tests will be done during the study to assess efficacy and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024140 | NIH | None | httpsreporternihgovquickSearchUL1RR024140 |