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Atorvastatin (Lipitor) to Prevent Bone Pain

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00120133
First received: July 8, 2005
Last updated: May 19, 2008
Last verified: July 2005

July 8, 2005
May 19, 2008
December 2004
Not Provided
Alleviation of bone pain by Atorvastatin compared to placebo by visual analogue pain scale.
Same as current
Complete list of historical versions of study NCT00120133 on ClinicalTrials.gov Archive Site
Changes in blood count and γδT cell count, 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.
Same as current
Not Provided
Not Provided
 
Atorvastatin (Lipitor) to Prevent Bone Pain
Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid

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.

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 Children's 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Osteoporosis
Drug: Atorvastatin
Not Provided
Srivastava T, Haney CJ, Alon US. Atorvastatin may have no effect on acute phase reaction in children after intravenous bisphosphonate infusion. J Bone Miner Res. 2009 Feb;24(2):334-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2007
Not Provided

Inclusion Criteria:

  • Children with various metabolic bone diseases and osteoporosis who are to initiate treatment with either pamidronate and/or zoledronic acid.
  • They should be 6 to 25 years old, able to understand the study, swallow pills and competent to complete the visual analogue pain scale.

Exclusion Criteria:

  • Children less than 6 years old or incompetent to complete the visual analogue pain scale.
  • Children with seizure disorder associated or triggered by fever.
  • Children known to have hypersensitivity reaction to statins, active liver disease or persistent elevated serum transaminases or CPK.
  • Children on erythromycin, cyclosporine, fibric acid, azole antifungals, cimetidine and spironolactone will be excluded.
Both
6 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120133
#04 10-119
Not Provided
Not Provided
Children's Mercy Hospital Kansas City
Not Provided
Principal Investigator: Tarak Srivastava, MD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP