Zoledronate for Osteopenia in Pediatric Crohn's

Osteoporosis Clinical Trial

Official title:

A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798473
• Other study ID #: MCH002-56
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2008
• Last updated: November 25, 2008
• Start date: September 2004
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Osteopenia
• Osteoporosis

Intervention

Drug:
• zoledronic acid
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes

Other:
• IV saline infusion

Locations

Country	Name	City	State
Canada	McGill University Health Center - Montreal Children's Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Crohn's and Colitis Foundation

Country where clinical trial is conducted

Canada, 

Outcome

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