Zoledronate for Osteopenia in Pediatric Crohn's

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Osteoporosis; Osteopenia
• Intervention / Treatment: Drug: zoledronic acid; Other: IV saline infusion

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3H 1P3
      • McGill University Health Center - Montreal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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; Other Names: zoledronate; zometa
Placebo Comparator: 2; IV saline infusion	Other: IV saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lumbar spine density by DEXA	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Crohn's and Colitis Foundation
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: November 25, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): November 26, 2008
• Last Update Submitted That Met QC Criteria: November 25, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Crohn's disease; Osteoporosis; Bisphosphonates; Osteopenia; Zoledronate
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Musculoskeletal Diseases; Gastroenteritis; Intestinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Crohn Disease; Osteoporosis; Bone Diseases, Metabolic; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: MCH002-56