Zoledronate for Osteopenia in Pediatric Crohn's

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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 been well studied and found to be effective in the treatment of osteopenia in menopausal women.

• Zoledronate is a very potent third generation bisphosphonate, that is safe and easy to administer, and has been found effective in the treatment of menopausal women with osteopenia.

Hypothesis: The investigators hypothesize that zoledronate can improve bone density in children and adolescents with Crohn's disease with osteopenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: Crohn's and Colitis Foundation
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.