Zoledronate for Osteopenia in Pediatric Crohn's - Full Text View

Sponsors and Collaborators:	McGill University Health Center Crohn's and Colitis Foundation
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00798473

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease Osteopenia Osteoporosis	Drug: zoledronic acid Other: IV saline infusion	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Osteoporosis

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

Lumbar spine density by DEXA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of effect by urinary bone metabolite markers [ Time Frame: 6, 12 months ] [ Designated as safety issue: No ]
safety and tolerability (side-effects, renal and liver function, biochemical parameters) [ Time Frame: 0, 3, 6, 12 months ] [ Designated as safety issue: Yes ]
Lumbar spine bone density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Total body bone density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Fractures [ Time Frame: 0,3,6,12 months ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	September 2004
Study Completion Date:	November 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator IV saline infusion	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.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798473

Locations

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

Sponsors and Collaborators

McGill University Health Center

Crohn's and Colitis Foundation

Investigators

Principal Investigator:	Sylviane Forget, MD MSc FRCPC	McGill University Health Center
Principal Investigator:	Celia Rodd, MD FRCPC	McGill University Health Center

More Information

No publications provided

Responsible Party:	McGill University Health Center ( Sylviane Forget, Assistant Professor of Pediatrics )
Study ID Numbers:	MCH002-56
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00798473 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by McGill University Health Center:

Crohn's disease
Osteopenia
Osteoporosis
Bisphosphonates
Zoledronate

Study placed in the following topic categories:

Crohn's Disease
Zoledronic acid
Ileitis
Gastrointestinal Diseases
Enteritis
Osteoporosis
Inflammatory Bowel Diseases
Bone Density Conservation Agents
Bone Diseases, Metabolic

Intestinal Diseases
Bone Diseases
Ileal Diseases
Diphosphonates
Digestive System Diseases
Musculoskeletal Diseases
Crohn Disease
Gastroenteritis

Additional relevant MeSH terms:

Zoledronic acid
Ileitis
Gastrointestinal Diseases
Enteritis
Physiological Effects of Drugs
Osteoporosis
Inflammatory Bowel Diseases
Bone Density Conservation Agents
Bone Diseases, Metabolic

Intestinal Diseases
Ileal Diseases
Bone Diseases
Pharmacologic Actions
Digestive System Diseases
Musculoskeletal Diseases
Crohn Disease
Gastroenteritis

ClinicalTrials.gov processed this record on September 10, 2009