Neoplasm MetastasisPhase 4NCT00434317

Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

A Phase 4 study testing Zoledronic acid in people with Neoplasm Metastasis, run by Novartis at 4 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasm Metastasis
What is being tested?: Zoledronic acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 4 sitesHungary
Study dates: Aug 2005to Apr 2008
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

Ambulatory patients >18 years
Proof of breast cancer or prostate cancer
Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
Negative pregnancy test
ECOG performance status of 0,1 or 2

Who cannot join

Patients with abnormal renal function
Patients with clinically symptomatic brain metastases
Known hypersensitivity on zoledronic acid or other bisphosphonates
Pregnancy or lactation
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

4 sites in 1 country.

Hungary4 sites

Novartis Investigative Site
Budapest
Novartis Investigative Site
Pécs
Novartis Investigative Site
Szeged
Novartis Investigative Site
Székesfehérvár

Other trials in Hungary

About this study

Official title: A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer

Conditions: Neoplasm Metastasis
Being tested: Zoledronic acid
Keywords: Metastasis, Neoplasm, pain, breast cancer, prostate cancer, bone metastasis
Medical subject headings: Neoplasm Metastasis, Neoplasms, Pain, Breast Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zoledronic acidDrug

Study groups in NCT00434317
Study group	Role	What they receive
ZOL446	Experimental	Not described Receives: Drug: Zoledronic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of pain assessed by a Visual Analogue Scale (VAS)
Measured: throughout the study

Secondary outcomes (1)

Quality of Life assessment at baseline and last visit
Measured: throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Apr 2008

First posted13 Feb 2007 (estimated)
Study startAug 2005
Primary completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neoplasm MetastasisStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00434317
Sponsor's protocol ID: CZOL446EHU03
Status last verified: Feb 2017
First submitted: 9 Feb 2007
Last updated: 23 Feb 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neoplasm Metastasis trials

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 Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer
ClinicalTrials.gov ID: NCT00434317
Acronym / sponsor ID: CZOL446EHU03
Conditions: Neoplasm Metastasis
Keywords: Metastasis, Neoplasm, pain, breast cancer, prostate cancer, bone metastasis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Apr 2008 (actual)
First posted: 13 Feb 2007 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ZOL446	Experimental	Drug: Zoledronic acid

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Ambulatory patients >18 years
Proof of breast cancer or prostate cancer
Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
Negative pregnancy test
ECOG performance status of 0,1 or 2

Key exclusion criteria (5 listed)

Patients with abnormal renal function
Patients with clinically symptomatic brain metastases
Known hypersensitivity on zoledronic acid or other bisphosphonates
Pregnancy or lactation
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	ZOL446

Primary outcome

Measurement of pain assessed by a Visual Analogue Scale (VAS)
Time frame: throughout the study

1 secondary outcome

Quality of Life assessment at baseline and last visit
Time frame: throughout the 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 23 Feb 2017.

Related trials for Neoplasm Metastasis

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin

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 study director

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 Neoplasm Metastasis, run by Novartis at 4 sites in Hungary.

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 5 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 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 Hungary. 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?

Measurement of pain assessed by a Visual Analogue Scale (VAS) (time frame: throughout the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00434317.

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.