Osteogenesis ImperfectaPhase 2NCT00131118
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
A Phase 2 study testing Zoledronic Acid in people with Osteogenesis Imperfecta, run by Novartis Pharmaceuticals at 10 sites in United States.
Trial summary
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Zoledronic Acid
- How many people
- 127 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2004to May 2007
- Phase
- Phase 2
- 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 1 year to 17 years
- All sexes
- Child
Who may be able to join
- Have completed the core CZOL446H2202 study
- Males or females between 1-17 years of age
Who cannot join
- Deformity or abnormality which would prevent spine bone density from being done
- Any surgical bone-lengthening procedure
- Any kidney diseases or abnormalities
- Low calcium or vitamin D levels in the blood
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Intermountains Orthopedics
Boise, Idaho, 83702
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital
Columbus, Ohio, 43205
Texas Children's Hospital
Houston, Texas, 77030
UCLA Medical Center-Dept of Pediatric Nephrology
Los Angeles, California, 90095
For information regarding facilities, please contact the Central Contact
Multiple Locations, New Jersey
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Children's Hospital
Omaha, Nebraska, 68198
Oregon Health Sciences University
Portland, Oregon, 97239
Alfred Dupont Hospital for Children
Wilmington, Delaware, 19899
About this study
Official title: Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Zoledronic Acid
- Keywords
- Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
Secondary outcomes (1)
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131118
- Sponsor's protocol ID
- CZOL446H2202E1
- Status last verified
- Nov 2016
- First submitted
- 15 Aug 2005
- Last updated
- 1 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT00131118
- Acronym / sponsor ID
- CZOL446H2202E1
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 17 Aug 2005 (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.
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Have completed the core CZOL446H2202 study
- Males or females between 1-17 years of age
Key exclusion criteria (5 listed)
- Deformity or abnormality which would prevent spine bone density from being done
- Any surgical bone-lengthening procedure
- Any kidney diseases or abnormalities
- Low calcium or vitamin D levels in the blood
- Other protocol-defined inclusion/exclusion criteria may apply.
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 Acid | Drug | – |
Primary outcome
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
1 secondary outcome
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
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 1 Jun 2017.
- Novartis patient recruitment websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic Acid in people with Osteogenesis Imperfecta, run by Novartis Pharmaceuticals at 10 sites in United States.
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 2 inclusion and 5 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202. 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 1 Jun 2017.