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Zoledronate for Osteopenia in Pediatric Crohn's

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00798473
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : November 26, 2008
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Osteopenia Osteoporosis Drug: zoledronic acid Other: IV saline infusion Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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



Primary Outcome Measures :
  1. Lumbar spine density by DEXA [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Duration of effect by urinary bone metabolite markers [ Time Frame: 6, 12 months ]
  2. safety and tolerability (side-effects, renal and liver function, biochemical parameters) [ Time Frame: 0, 3, 6, 12 months ]
  3. Lumbar spine bone density [ Time Frame: 12 months ]
  4. Total body bone density [ Time Frame: 12 months ]
  5. Fractures [ Time Frame: 0,3,6,12 months ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Crohn's and Colitis Foundation
Investigators
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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
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Responsible Party: Sylviane Forget, Assistant Professor of Pediatrics, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00798473    
Other Study ID Numbers: MCH002-56
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: November 2008
Keywords provided by McGill University Health Centre/Research Institute of the McGill University Health Centre:
Crohn's disease
Osteopenia
Osteoporosis
Bisphosphonates
Zoledronate
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs