Osteogenesis ImperfectaPhase 2NCT00063479
Bisphosphonate Treatment of 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
The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Zoledronic Acid
- How many people
- 158 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2003to 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or Female children between 3 months and 17 years old
- OI type I, III or IV
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
Intermountain Orthopedics
Boise, Idaho, 83702
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital
Columbus, Ohio, 43205
Texas Children's Hosptial
Houston, Texas, 77030
UCLA - Division of Pediatric Nephrology
Los Angeles, California, 90024
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Children's Hospital
Omaha, Nebraska, 68198
St. Jude Children's Research Hospital
Peoria, Illinois, 61637
Oregon Health Sciences University
Portland, Oregon, 97201
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19899
About this study
The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Zoledronic Acid
- Keywords
- Osteogenesis Imperfecta, OI, bone markers, fracture, bone loss, pediatric, bisphosphonate, brittle bone disease, pamidronate
- Medical subject headings
- Osteogenesis Imperfecta, Fractures, Bone, Bone Diseases, Metabolic
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.
Change in lumbar spine bone mineral density at month 12 relative to baseline
Secondary outcomes (1)
Change in Z score of the lumbar spine at month 12 relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2003 (estimated)
- Study startJun 2003
- 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
- 158 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063479
- Sponsor's protocol ID
- CZOL446H2202
- Status last verified
- May 2017
- First submitted
- 27 Jun 2003
- 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
- Bisphosphonate Treatment of Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT00063479
- Acronym / sponsor ID
- CZOL446H2202
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis Imperfecta, OI, bone markers, fracture, bone loss, pediatric, bisphosphonate, brittle bone disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 30 Jun 2003 (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.
The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or Female children between 3 months and 17 years old
- OI type I, III or IV
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
Change in lumbar spine bone mineral density at month 12 relative to baseline
1 secondary outcome
Change in Z score of the lumbar spine at month 12 relative to baseline
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.
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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?
Change in lumbar spine bone mineral density at month 12 relative to baseline. 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.