Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Alleviation of bone pain by Atorvastatin compared to placebo by visual analogue pain scale.
Tarak Srivastava, MD
Children's Mercy Hospital
United States: Institutional Review Board
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