Cancer ProstatePhase 3NCT00172055
Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
A Phase 3 study testing Zoledronic acid in people with Cancer Prostate, run by Novartis Pharmaceuticals at 19 sites in Belgium.
Trial summary
The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Prostate
- What is being tested?
- Zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 19 sitesBelgium
- Study dates
- Dec 2004to Jul 2009
- 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
- All stages of prostate cancer without bone metastases
- No evidence of severe osteoporosis
- ECOG performance status 0, 1 or 2
Who cannot join
- Surgery / fracture at the lumbosacral spine, bilateral hip implants
- Evidence of metabolic bone diseases,
- Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment
- Abnormal kidney or liver function
- Other cancers within the last 5 years
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Belgium19 sites
Novartis Investigative Site
Anderlecht
Novartis Investigative Site
Antwerp
Novartis Investigative Site
Bruges
Novartis Investigative Site
Brussels
Novartis Investigative Site
Charleroi
Novartis Investigative Site
Edegem
Novartis Investigative Site
Ghent
Novaris Investigative Site
Gosselies
Novartis Investigative Site
Kortrijk
Novartis Investigative Site
Leper
Novartis Investigative Site
Leuven
Novaris Investigative Site
Libramont
Novartis Investigative Site
Mont-Godinne
Novartis Investigative Site
Roeselare
Novartis Investigative Site
Tongeren
Novartis Investigative Site
Tournai
Novartis Investigative Site
Turnhout
Novartis Investigative Site
Wilrijk
Novartis Investigative Site
Woluwe-Saint-Lambert
About this study
The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.
- Conditions
- Cancer Prostate
- Being tested
- Zoledronic acid
- Keywords
- Zoledronic acid, Zometa, prostate cancer, osteoporosis
- Medical subject headings
- Prostatic Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| ZOL446 (zoledronic acid) | Experimental | Not described Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.
Measured: at 6 months
Secondary outcomes (1)
If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ProstateStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172055
- Sponsor's protocol ID
- CZOL446GBE03
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 6 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
- ClinicalTrials.gov ID
- NCT00172055
- Acronym / sponsor ID
- CZOL446GBE03
- Conditions
- Cancer Prostate
- Keywords
- Zoledronic acid, Zometa, prostate cancer, osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 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.
The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZOL446 (zoledronic acid) | 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 (3 listed)
- All stages of prostate cancer without bone metastases
- No evidence of severe osteoporosis
- ECOG performance status 0, 1 or 2
Key exclusion criteria (6 listed)
- Surgery / fracture at the lumbosacral spine, bilateral hip implants
- Evidence of metabolic bone diseases,
- Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment
- Abnormal kidney or liver function
- Other cancers within the last 5 years
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 (zoledronic acid) |
Primary outcome
If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.
Time frame: at 6 months
1 secondary outcome
If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases
Time frame: at 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 6 Mar 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 Pharmeceuticals
19 sites 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 Cancer Prostate, run by Novartis Pharmaceuticals at 19 sites in Belgium.
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 3 inclusion and 6 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Belgium. 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?
If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy. (time frame: at 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 6 Mar 2017.