Breast CancerPhase 4NCT00029224
Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
A Phase 4 study testing zoledronic acid in people with Breast Cancer and Multiple Myeloma, run by Novartis at 7 sites in United States.
Trial summary
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Multiple Myeloma, Prostate Cancer
- What is being tested?
- zoledronic acid
- How many people
- 500 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2001to Nov 2002
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Greater than 18 years of age
- Proof of breast cancer, multiple myeloma or prostate cancer
- Diagnosis of at least one cancer-related bone lesion
- If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
- ECOG performance status of 0,1 or 2
Show all 12Show fewer
- Ability to read, understand and write English or Spanish language
- Normal renal function
- Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria
- clinically symptomatic brain metastases
- hypersensitivity to Zometa or other bisphosphonates
- pregnant or lactating
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Hematology-Oncology Associates PC
Albuquerque, New Mexico, 87102
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87102
Osceola Cancer Center
Kissimmee, Florida, 34741
Nevada Cancer Center
Las Vegas, Nevada, 89109
Hematology Oncology Associates, PC
Medforo, Oregon, 97504
Virginia Physicians, Inc
Richmond, Virginia, 23294
Stockton Hematology Oncology Medical Group
Stockton, California, 95204
About this study
Official title: A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.
- Conditions
- Breast Cancer, Multiple Myeloma, Prostate Cancer
- Being tested
- zoledronic acid
- Keywords
- bone lesions, breast cancer, multiple myeloma, prostate cancer, bone metastases, pain
- Medical subject headings
- Breast Neoplasms, Multiple Myeloma, Prostatic Neoplasms, Pain
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.
Pain score assessed by change from baseline
Secondary outcomes (3)
Quality of life
Time in infusion chair
Safety assessed by adverse events (AEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2002 (estimated)
- Study startOct 2001
- Primary completionNov 2002
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029224
- Sponsor's protocol ID
- CZOL446EUS16
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2002
- Last updated
- 1 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions
- ClinicalTrials.gov ID
- NCT00029224
- Acronym / sponsor ID
- CZOL446EUS16
- Conditions
- Breast Cancer, Multiple Myeloma, Prostate Cancer
- Keywords
- bone lesions, breast cancer, multiple myeloma, prostate cancer, bone metastases, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 10 Jan 2002 (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.
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent
- Greater than 18 years of age
- Proof of breast cancer, multiple myeloma or prostate cancer
- Diagnosis of at least one cancer-related bone lesion
- If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
Key exclusion criteria (0 listed)
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
Pain score assessed by change from baseline
3 secondary outcomes
Quality of life
Time in infusion chair
Safety assessed by adverse events (AEs)
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 Feb 2012.
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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.
7 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 Breast Cancer and Multiple Myeloma, run by Novartis at 7 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 12 inclusion and 0 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 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Pain score assessed by change from 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 Feb 2012.