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Atorvastatin (Lipitor) to Prevent Bone Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120133
First Posted: July 15, 2005
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Mercy Hospital Kansas City
  Purpose
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.

Condition Intervention
Osteoporosis Drug: Atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Alleviation of bone pain by Atorvastatin compared to placebo by visual analogue pain scale.

Secondary Outcome Measures:
  • 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.

Enrollment: 12
Study Start Date: December 2004
Study Completion Date: December 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120133


Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Tarak Srivastava, MD Children's Mercy Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00120133     History of Changes
Other Study ID Numbers: #04 10-119
First Submitted: July 8, 2005
First Posted: July 15, 2005
Last Update Posted: May 20, 2008
Last Verified: July 2005

Keywords provided by Children's Mercy Hospital Kansas City:
Osteoporosis
Bisphosphonates
Atorvastatin

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors