Zoledronate for Osteopenia in Pediatric Crohn's

Osteoporosis Clinical Trial

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

Status Completed

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

• Crohn Disease
• Crohn's Disease
• Osteopenia
• Osteoporosis

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