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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Lumbar spine density by DEXA
Time frame: 6 months
Duration of effect by urinary bone metabolite markers
Time frame: 6, 12 months
safety and tolerability (side-effects, renal and liver function, biochemical parameters)
Time frame: 0, 3, 6, 12 months
Lumbar spine bone density
Time frame: 12 months
Total body bone density
Time frame: 12 months
Fractures
Time frame: 0,3,6,12 months
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