Osteoporosis Clinical Trial
Official title:
A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
Verified date | November 2008 |
Source | McGill University Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | November 2008 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 18 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center | Crohn's and Colitis Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lumbar spine density by DEXA | 6 months | No | |
Secondary | Duration of effect by urinary bone metabolite markers | 6, 12 months | No | |
Secondary | safety and tolerability (side-effects, renal and liver function, biochemical parameters) | 0, 3, 6, 12 months | Yes | |
Secondary | Lumbar spine bone density | 12 months | No | |
Secondary | Total body bone density | 12 months | No | |
Secondary | Fractures | 0,3,6,12 months | No |
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