Zoledronate for Osteopenia in Pediatric Crohn's

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Crohn's Disease, Osteopenia, Osteoporosis

Intervention / Treatment
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* Drug: zoledronic acid
* Other: IV saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 6 to 18, 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: renal dysfunction, 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg | Drug: zoledronic acid<br>* Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes<br>* Other names: zometa;|
| Placebo Comparator: 2<br>IV saline infusion | Other: IV saline infusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar spine density by DEXA |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of effect by urinary bone metabolite markers |  | 6, 12 months | 
| safety and tolerability (side-effects, renal and liver function, biochemical parameters) |  | 0, 3, 6, 12 months | 
| Lumbar spine bone density |  | 12 months | 
| Total body bone density |  | 12 months | 
| Fractures |  | 0,3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Osteopenia, Osteoporosis, Bisphosphonates, Zoledronate