Atorvastatin (Lipitor) to Prevent Bone Pain
Information source: Children's Mercy Hospital Kansas City
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Atorvastatin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Children's Mercy Hospital Kansas City Official(s) and/or principal investigator(s):
Tarak Srivastava, MD, Principal Investigator, Affiliation: Children's Mercy Hospital
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.
Clinical Details
Official title: Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Alleviation of bone pain by Atorvastatin compared to placebo by visual analogue pain scale.
Secondary outcome: 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.
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 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.
Eligibility
Minimum age: 6 Years.
Maximum age: 25 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Children's Mercy Hospital, Kansas City, Missouri 64108, United States
Additional Information
Starting date: December 2004
Ending date: December 2007
Last updated: May 19, 2008
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