Zoledronate for Osteopenia in Pediatric Crohn's
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|ClinicalTrials.gov Identifier: NCT00798473|
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : November 26, 2008
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Osteopenia Osteoporosis||Drug: zoledronic acid Other: IV saline infusion||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||November 2008|
Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg
Drug: zoledronic acid
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
Placebo Comparator: 2
IV saline infusion
Other: IV saline infusion
- Lumbar spine density by DEXA [ Time Frame: 6 months ]
- Duration of effect by urinary bone metabolite markers [ Time Frame: 6, 12 months ]
- safety and tolerability (side-effects, renal and liver function, biochemical parameters) [ Time Frame: 0, 3, 6, 12 months ]
- Lumbar spine bone density [ Time Frame: 12 months ]
- Total body bone density [ Time Frame: 12 months ]
- Fractures [ Time Frame: 0,3,6,12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798473
|McGill University Health Center - Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H 1P3|
|Principal Investigator:||Sylviane Forget, MD MSc FRCPC||McGill University Health Centre/Research Institute of the McGill University Health Centre|
|Principal Investigator:||Celia Rodd, MD FRCPC||McGill University Health Centre/Research Institute of the McGill University Health Centre|