Status:
COMPLETED
Atorvastatin (Lipitor) to Prevent Bone Pain
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Osteoporosis
Eligibility:
All Genders
6-25 years
Phase:
NA
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 sympt...
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00120133
Start Date
December 1 2004
End Date
December 1 2007
Last Update
May 20 2008
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108