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Clinical Trial 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.


Clinical Trial 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 random to one of two groups: either treatment with zoledronate, or a placebo.

- Neither the participants or the physicians are aware of which group each participant is in.

- Participants are followed every three months for one year, and assessed with blood tests, urine tests, physical examination, diet questionnaire and exercise questionnaire.

- Participants have a repeat DEXA scan at 6 and 12 months after beginning the study.

- Once all participants are enrolled and followed for one whole year, we will compare the bone density of the group treated with zoledronate with the group treated with placebo. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00798473
Study type Interventional
Source McGill University Health Center
Contact
Status Completed
Phase Phase 3
Start date September 2004
Completion date November 2008

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