Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
13 participants
INTERVENTIONAL
2004-09-30
2008-11-30
Brief Summary
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* 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
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg
zoledronic acid
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
2
IV saline infusion
IV saline infusion
Interventions
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zoledronic acid
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
IV saline infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
18 Years
ALL
No
Sponsors
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Crohn's and Colitis Foundation
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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McGill University Health Center
Principal Investigators
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Sylviane Forget, MD MSc FRCPC
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Celia Rodd, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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MCH002-56
Identifier Type: -
Identifier Source: org_study_id