Crohn's DiseasePhase 3NCT00798473
Zoledronate for Osteopenia in Pediatric Crohn's
A Phase 3 study testing zoledronic acid and IV saline infusion in people with Crohn's Disease and Osteopenia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn's Disease, Osteopenia, Osteoporosis
- What is being tested?
- zoledronic acid and IV saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Nov 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
About this study
Official title: A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
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.
Read the 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.
- Conditions
- Crohn's Disease, Osteopenia, Osteoporosis
- Being tested
- zoledronic acid, IV saline infusion
- Keywords
- Crohn's disease, Osteopenia, Osteoporosis, Bisphosphonates, Zoledronate
- Medical subject headings
- Crohn Disease, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Also called zoledronate, zometa
Zoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes
IV saline infusionOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg Receives: Drug: zoledronic acid |
| 2 | Placebo comparator | IV saline infusion Receives: Other: IV saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine density by DEXA
Measured: 6 months
Secondary outcomes (5)
Duration of effect by urinary bone metabolite markers
Measured: 6, 12 months
safety and tolerability (side-effects, renal and liver function, biochemical parameters)
Measured: 0, 3, 6, 12 months
Lumbar spine bone density
Measured: 12 months
Total body bone density
Measured: 12 months
Fractures
Measured: 0,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startSep 2004
- Primary completionSep 2007
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Investigators
- Sylviane Forget, MD MSc FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreCelia Rodd, MD FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798473
- Sponsor's protocol ID
- MCH002-56
- Status last verified
- Nov 2008
- First submitted
- 25 Nov 2008
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00798473
- Acronym / sponsor ID
- MCH002-56
- Conditions
- Crohn's Disease, Osteopenia, Osteoporosis
- Keywords
- Crohn's disease, Osteopenia, Osteoporosis, Bisphosphonates, Zoledronate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- Sep 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: zoledronic acidZoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg |
| 2 | Placebo comparator | Other: IV saline infusionIV saline infusion |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).)
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zoledronic acidAlso: zoledronate, zometaZoledronic acid 0.066 mg/kg (maximum 4 mg) given as a single intravenous infusion over ten minutes | Drug | 1 |
| IV saline infusion | Other | 2 |
Primary outcome
Lumbar spine density by DEXA
Time frame: 6 months
5 secondary outcomes
Duration of effect by urinary bone metabolite markers
Time frame: 6, 12 months
safety and tolerability (side-effects, renal and liver function, biochemical parameters)
Time frame: 0, 3, 6, 12 months
Lumbar spine bone density
Time frame: 12 months
Total body bone density
Time frame: 12 months
Fractures
Time frame: 0,3,6,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylviane Forget, MD MSc FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Celia Rodd, MD FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zoledronic acid and IV saline infusion in people with Crohn's Disease and Osteopenia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar spine density by DEXA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2008.