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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on July 23, 2014