Zoledronate for Osteopenia in Pediatric Crohn's
Primary Purpose
Crohn's Disease, Osteopenia, Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
zoledronic acid
IV saline infusion
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Osteopenia, Osteoporosis, Bisphosphonates, Zoledronate
Eligibility 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.
Sites / Locations
- McGill University Health Center - Montreal Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg
IV saline infusion
Outcomes
Primary Outcome Measures
Lumbar spine density by DEXA
Secondary Outcome Measures
Duration of effect by urinary bone metabolite markers
safety and tolerability (side-effects, renal and liver function, biochemical parameters)
Lumbar spine bone density
Total body bone density
Fractures
Full Information
NCT ID
NCT00798473
First Posted
November 25, 2008
Last Updated
November 25, 2008
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Crohn's and Colitis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00798473
Brief Title
Zoledronate for Osteopenia in Pediatric Crohn's
Official Title
A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Crohn's and Colitis Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Osteopenia, Osteoporosis
Keywords
Crohn's disease, Osteopenia, Osteoporosis, Bisphosphonates, Zoledronate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
IV saline infusion
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Other Intervention Name(s)
zoledronate, zometa
Intervention Description
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
Intervention Type
Other
Intervention Name(s)
IV saline infusion
Primary Outcome Measure Information:
Title
Lumbar spine density by DEXA
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Duration of effect by urinary bone metabolite markers
Time Frame
6, 12 months
Title
safety and tolerability (side-effects, renal and liver function, biochemical parameters)
Time Frame
0, 3, 6, 12 months
Title
Lumbar spine bone density
Time Frame
12 months
Title
Total body bone density
Time Frame
12 months
Title
Fractures
Time Frame
0,3,6,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylviane Forget, MD MSc FRCPC
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Celia Rodd, MD FRCPC
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center - Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
12. IPD Sharing Statement
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Zoledronate for Osteopenia in Pediatric Crohn's
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