Treatment of Bone MetastasesPhase 3NCT00219258
Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
A Phase 3 study testing Zoledronic acid in people with Treatment of Bone Metastases, run by Novartis at 1 site in China.
Trial summary
Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Bone Metastases
- What is being tested?
- Zoledronic acid
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jul 2005to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions
- Significant bone pain
Who cannot join
- Poor renal function
- Use of other investigational drugs within 30 days of visit 2
- Dental or other surgery to the jaw within 6 weeks of screening, or planned during the 4 week study
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases.
- Conditions
- Treatment of Bone Metastases
- Being tested
- Zoledronic acid
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.
To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma
Secondary outcomes (1)
Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Bone MetastasesStudies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219258
- Sponsor's protocol ID
- CZOL446E2301
- Status last verified
- Nov 2009
- First submitted
- 12 Sep 2005
- Last updated
- 23 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00219258
- Acronym / sponsor ID
- CZOL446E2301
- Conditions
- Treatment of Bone Metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 22 Sep 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.
Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions
- Significant bone pain
Key exclusion criteria (4 listed)
- Poor renal function
- Use of other investigational drugs within 30 days of visit 2
- Dental or other surgery to the jaw within 6 weeks of screening, or planned during the 4 week study
- Other protocol-defined 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
To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma
1 secondary outcome
Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio).
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 Nov 2009.
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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 study chair
Novartis
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 in people with Treatment of Bone Metastases, run by Novartis at 1 site 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 4 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 Nov 2009. 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 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 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?
To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma. 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 Nov 2009.