Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120133
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2005-07-08
Brief Title:
Atorvastatin Lipitor to Prevent Bone Pain
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Use of Atorvastatin Lipitor to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid
Status:
COMPLETED
Status Verified Date:
2005-07
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:
In the proposed randomized double blind cross-over placebo controlled study the researchers intend to investigate if Atorvastatin FDA approved statin for children can be used to alleviate the symptom of bone pain acute phase reaction that is commonly associated with initial doses of pamidronate or zoledronic acid and also the mechanism that underlies this proposed beneficial effect of Atorvastatin The primary outcome studied will be alleviation of bone pain by Atorvastatin compared to placebo by visual analogue pain scale in children treated with pamidronate or zoledronic acid The secondary outcome investigated will be changes in blood count and γδT cell count C-reactive protein CRP and cytokine levels of interleukin 6 IL-6 tumor necrosis factor-alpha TNF-α and gamma interferon γ-IFN following treatment with Atorvastatin compared to placebo
Detailed Description:
The proposed study is a double blind cross-over placebo controlled randomized clinical study that would be conducted in the Metabolic Bone Clinic of The Childrens Mercy Hospital This is a pilot study and a more comprehensive study will be designed only if the results from this pilot study are significant In our proposed double blind cross-over placebo controlled pilot study we will have a total of 12 children who will receive either placebo or Atorvastatin in a randomized cross-over design The pilot study with a sample of 12 in a cross-over trial will provide reasonably stable estimates even though it is unlikely to provide statistical significance on its own but will help plan further large scale studies
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