Paget's Disease of BonePhase 4NCT00774020
Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
A Phase 4 study testing Zoledronic acid in people with Paget's Disease of Bone, run by Novartis Pharmaceuticals at 4 sites in China.
Trial summary
The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Paget's Disease of Bone
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesChina
- Study dates
- 30 Oct 2008to 14 Jan 2011
- Phase
- Phase 4
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of PDB by radiological reports
- Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
Who cannot join
- History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;
- History of malignancy of any organ system
- Severe liver or bladder disease;
- Calculated creatinine clearance < 35 mL/min at baseline;
- Hypocalcaemia;
- Patients with pre-existing dental diseases or who predict to have dental surgeries during the study;
- Evidence of vitamin D deficiency.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Novartis Investigative Site
Beijing
Novartis Investigative site
Guangzhou
Novartis Investigative site
Nanjing
Novartis Investigative site
Shanghai
About this study
Official title: A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PDB) in China
The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).
- Conditions
- Paget's Disease of Bone
- Being tested
- Zoledronic acid
- Keywords
- Paget's Disease of Bone, Serum Alkaline Phosphatase
- Medical subject headings
- Osteitis Deformans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
5mg, i.v. single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP.
Measured: at the end of 3 months and 6 months
Secondary outcomes (2)
The percent change from baseline in total Serum Alkaline Phosphatase (SAP).
Measured: at the end of 3 months and 6 months
The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).
Measured: at the end of 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study start30 Oct 2008
- Primary completion14 Jan 2011
- Study completion14 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paget's Disease of BoneStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Principal investigator, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774020
- Sponsor's protocol ID
- CZOL446K2419
- Status last verified
- Feb 2017
- First submitted
- 15 Oct 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PDB) in China
- ClinicalTrials.gov ID
- NCT00774020
- Acronym / sponsor ID
- CZOL446K2419
- Conditions
- Paget's Disease of Bone
- Keywords
- Paget's Disease of Bone, Serum Alkaline Phosphatase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2008 (actual)
- Primary completion
- 14 Jan 2011 (actual)
- Study completion
- 14 Jan 2011 (actual)
- First posted
- 16 Oct 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.
The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zoledronic acid |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of PDB by radiological reports
- Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
Key exclusion criteria (8 listed)
- History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;
- History of malignancy of any organ system
- Severe liver or bladder disease;
- Calculated creatinine clearance < 35 mL/min at baseline;
- Hypocalcaemia;
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 acid5mg, i.v. single dose | Drug | 1 |
Primary outcome
The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP.
Time frame: at the end of 3 months and 6 months
2 secondary outcomes
The percent change from baseline in total Serum Alkaline Phosphatase (SAP).
Time frame: at the end of 3 months and 6 months
The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).
Time frame: at the end of 3 months and 6 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 23 Feb 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.
Novartis Pharmaceuticals principal investigator
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid in people with Paget's Disease of Bone, run by Novartis Pharmaceuticals at 4 sites in China.
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 8 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP. (time frame: at the end of 3 months and 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 23 Feb 2017.