Zoledronate for Osteopenia in Pediatric Crohn's

Phase 3

Completed

• Conditions: Crohn's Disease; Osteopenia; Osteoporosis
• Interventions: Drug: zoledronic acid; Other: IV saline infusion

• Registration Number: NCT00798473
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-09
• Status Verified: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Last Update Submitted: 2008-11-25
• Study First Posted: 2008-11-26
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	zoledronic acid	Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg
2	IV saline infusion	IV saline infusion

Primary Outcome Measures

Name	Time	Method
Lumbar spine density by DEXA	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

McGill University Health Center - Montreal Children's Hospital; 🇨🇦 Montreal, Quebec, Canada