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Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid


N/A
6 Years
25 Years
Not Enrolling
Both
Osteoporosis

Thank you

Trial Information

Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

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

Principal Investigator

Tarak Srivastava, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Mercy Hospital

Authority:

United States: Institutional Review Board

Study ID:

#04 10-119

NCT ID:

NCT00120133

Start Date:

December 2004

Completion Date:

December 2007

Related Keywords:

  • Osteoporosis
  • Osteoporosis
  • Bisphosphonates
  • Atorvastatin
  • Osteoporosis

Name

Location

Children's Mercy HospitalKansas City, Missouri  64108