Osteoporosis Clinical Trial
Official title:
A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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