Use of Atorvastatin (Lipitor) to Prevent Bone Pain Following Infusion of Pamidronate or Zoledronic Acid
6 Years
25 Years
Both
Osteoporosis
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 Hospital | Kansas City, Missouri 64108 |
