NCT00798473

Zoledronate for Osteopenia in Pediatric Crohn's

A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Crohn's Disease
• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
DRUG	zoledronic acid	Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
OTHER	IV saline infusion

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-09-01
• Completion: 2008-11-01
• First posted: 2008-11-26
• Last updated: 2008-11-26

Locations

1 site across 1 country: Canada