Atorvastatin (Lipitor) to Prevent Bone Pain - Full Text View

Sponsor:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00120133

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:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

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

Ages Eligible for Study:	6 Years to 25 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Children's Mercy Hospital Kansas City

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	#04 10-119
Study First Received:	July 8, 2005
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00120133 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

Osteoporosis
Bisphosphonates
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Osteoporosis
Bone Diseases, Metabolic
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Therapeutic Uses
Atorvastatin

ClinicalTrials.gov processed this record on November 30, 2009