NCT00798473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

Enrollment Period

3 years

First QC Date

November 25, 2008

Last Update Submit

November 25, 2008

Conditions

Crohn's DiseaseOsteopeniaOsteoporosis

Keywords

Crohn's diseaseOsteopeniaOsteoporosisBisphosphonatesZoledronate

Outcome Measures

Primary Outcomes (1)

  • Lumbar spine density by DEXA

    6 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg

Drug: zoledronic acid

2

PLACEBO COMPARATOR

IV saline infusion

Other: IV saline infusion

Interventions

zoledronic acidDRUG

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

Also known as: zoledronate, zometa
1
IV saline infusionOTHER
2

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Center - Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

MeSH Terms

Conditions

Crohn DiseaseBone Diseases, MetabolicOsteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 26, 2008

Study Start

September 1, 2004

Primary Completion

September 1, 2007

Study Completion

November 1, 2008

Last Updated

November 26, 2008

Record last verified: 2008-11

Locations

CA(1)