Atorvastatin (Lipitor) to Prevent Bone Pain

NCT00120133 | Completed

• 1 other identifier: #04 10-119
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis

Keywords

Osteoporosis; Bisphosphonates; Atorvastatin

Outcome Measures

Primary Outcomes (1)

• Alleviation of bone pain by Atorvastatin compared to placebo by visual analogue pain scale.

Secondary Outcomes (1)

• 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.

Interventions

Atorvastatin DRUG

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• 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. doi: 10.1359/jbmr.081016.

  PMID: 18847329 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Tarak Srivastava, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 15, 2005
• Study Start: December 1, 2004
• Study Completion: December 1, 2007
• Last Updated: May 20, 2008

Record last verified: 2005-07

Locations

US (1)