Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159419
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2005-09-07
Brief Title:
Bisphosphonate Therapy for Osteogenesis Imperfecta
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Bisphosphonate Therapy for Osteogenesis Imperfecta
Status:
COMPLETED
Status Verified Date:
2017-05
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:
None
Brief Summary:
The study is designed to evaluate the efficacy and safety of Bisphosphonate Therapy for Osteogenesis Imperfecta OI We the researchers at Indiana University School of Medicine are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures
Detailed Description:
The study is designed to evaluate the efficacy and safety of Bisphosphonate Therapy for Osteogenesis Imperfecta OI OI is an inherited disorder of collagen synthesis Collagen is the major structural protein of the matrix of tendons skin and bones Affected persons have low bone mineral density and experience multiple fractures and progressive bony deformity In its most severe form the disorder is lethal in infancy We plan to characterize the changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous bisphosphonate therapy in a group of children with OI
Additionally we have begun to treat patients with OI and other conditions of low bone mineralization for age who are not eligible for the standard protocol too young history of abdominal pain etc with bisphosphonate We also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta in order to determine if they also have osteoporosis
Additionally we have begun to treat patients with OI and other conditions of low bone mineralization for age who are not eligible for the standard protocol too young history of abdominal pain etc with bisphosphonate We also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta in order to determine if they also have osteoporosis
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