Status:
COMPLETED
Zoledronate for Osteopenia in Pediatric Crohn's
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Crohn's and Colitis Foundation
Conditions:
Crohn's Disease
Osteopenia
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
Background: * Up to 30% of children and adolescents with Crohn's disease have decreased bone strength, or decrease bone density, called osteopenia. * Bisphosphonates are a group of drugs that have be...
Detailed Description
* This study is recruiting 40 children and adolescents, aged 6 to 18, who have a proven abnormal bone density as measured on a special type of x-ray called a DEXA-scan. * Participants are allocated at...
Eligibility Criteria
Inclusion
- patients aged 6 to 18,
- diagnosed with Crohn's disease with osteopenia,
- a minimum of 6 months of adequate calcium and vitamin D intake. (Osteopenia was defined for the purposes of this study as: Z-score lumber spine BMD by DEXA of -2.0 or less, or -1.5 and a risk factor (either steroid use for 6 months or more or decrease of 0.5 z-score in the preceding 12 months).)
Exclusion
- renal dysfunction,
- insufficient calcium or vitamin D intake,
- current medication or condition affecting bone metabolism,
- documented fracture, previously diagnosed bone disease,
- documented intolerance/hypersensitivity to bisphosphonates,
- previous treatment with bisphosphonates within the last 6 months.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00798473
Start Date
September 1 2004
End Date
November 1 2008
Last Update
November 26 2008
Active Locations (1)
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1
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3