Clinical trial NCT00798473: Zoledronate for Osteopenia in Pediatric Crohn's
Official title: A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Osteopenia
Osteoporosis
Keywords: Crohn's disease
Osteopenia
Osteoporosis
Bisphosphonates
Zoledronate
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2008-11-26
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lumbar spine density by DEXA
timeFrame: 6 months
Secondary outcomes:
measure: Duration of effect by urinary bone metabolite markers
timeFrame: 6, 12 months
measure: safety and tolerability (side-effects, renal and liver function, biochemical parameters)
timeFrame: 0, 3, 6, 12 months
measure: Lumbar spine bone density
timeFrame: 12 months
measure: Total body bone density
timeFrame: 12 months
measure: Fractures
timeFrame: 0,3,6,12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center - Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Sylviane Forget, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Celia Rodd, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: