Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099177
Status:
TERMINATED
Last Update Posted:
2017-08-16
First Post:
2004-12-10
Brief Title:
A Study to Assess the Efficacy of IntravenousOral Bondronat Ibandronate in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain
Status:
TERMINATED
Status Verified Date:
2017-08
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:
This 2 arm study will compare the efficacy of a regimen of intravenous iv and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain Patients will be randomized to receive either Bondronat 6mg iv on days 1 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24 or zoledronic acid 4mg iv on day 1 and then every 3-4 weeks The anticipated time of study treatment is 6-12 months and the target sample size is 100-500 individuals
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