Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01799798
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2013-02-14
Brief Title:
Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
TRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMAB
Status:
COMPLETED
Status Verified Date:
2015-01
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-AK
Brief Summary:
Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children 5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta Efficacy will be assessed by DXA measurements at the lumbar spine of the areal bone mineral density BMD which is the most frequently used parameter in trials investigating osteoporosis
The hypothesis of the study is
Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast maturation Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL BMD could be increased during a 36 week treatment course with denosumab measured after 48 weeks
The hypothesis of the study is
Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast maturation Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL BMD could be increased during a 36 week treatment course with denosumab measured after 48 weeks
Detailed Description:
None
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