Prostate CancerPhase 4NCT00242554
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
A Phase 4 study testing Zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals.
Trial summary
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Zoledronic acid
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Jul 2007
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Histological confirmed diagnosis of carcinoma of the prostate
- Current or previous evidence of metastatic disease to the bone
- Receiving currently or not, hormonal therapy
- ECOG performance status of 0, 1, or 2
Who cannot join
- Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
- Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L).
- WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L.
- Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
- Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
- Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.
- Other protocol-related inclusion / exclusion criteria may apply
About this study
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability
- Conditions
- Prostate Cancer
- Being tested
- Zoledronic acid
- Keywords
- Prostate Cancer, Bone Metastases, Zoledronic acid
- Medical subject headings
- Prostatic Neoplasms
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 evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
Secondary outcomes (1)
No secondary outcomes/objectives planned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startOct 2002
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242554
- Sponsor's protocol ID
- CZOL446EMX01
- Status last verified
- Feb 2017
- First submitted
- 9 Oct 2005
- 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
- Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
- ClinicalTrials.gov ID
- NCT00242554
- Acronym / sponsor ID
- CZOL446EMX01
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Bone Metastases, Zoledronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jul 2007 (actual)
- First posted
- 20 Oct 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.
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Histological confirmed diagnosis of carcinoma of the prostate
- Current or previous evidence of metastatic disease to the bone
- Receiving currently or not, hormonal therapy
- ECOG performance status of 0, 1, or 2
Key exclusion criteria (7 listed)
- Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
- Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L).
- WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L.
- Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
- Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
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 evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
1 secondary outcome
No secondary outcomes/objectives planned
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 study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals.
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 7 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.
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?
To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain. 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.