Crohn's Disease, Osteopenia, Osteoporosis
Conditions
Keywords
Crohn's disease, Osteopenia, Osteoporosis, Bisphosphonates, Zoledronate
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.
Interventions
DRUGzoledronic acid
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
OTHERIV saline infusion
Sponsors
Crohn's and Colitis Foundation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar spine density by DEXA | 6 months |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed