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A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
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.
* 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.
Age
6 - 18 years
Sex
ALL
Healthy Volunteers
No
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Start Date
September 1, 2004
Primary Completion Date
September 1, 2007
Completion Date
November 1, 2008
Last Updated
November 26, 2008
13
ACTUAL participants
zoledronic acid
DRUG
IV saline infusion
OTHER
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06918808