Trials Sponsors Conditions Drugs Pricing

Conditions

Crohn's Disease Osteopenia Osteoporosis

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

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

IV saline infusionOther

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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,

Sponsors & Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre
Otherlead
Crohn's and Colitis Foundation
Othercollaborator

Study Sites (1)

McGill University Health Center - Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

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)

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

Enrollment

13 participants (actual enrollment reported by the registry).

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 2004

Date type not reported

This date has not been verified as actual or estimated.

Zoledronate for Osteopenia in Pediatric Crohn's

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations