Prostate CancerPhase 4NCT00334139
Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
A Phase 4 study testing Zoledronic Acid in people with Prostate Cancer and Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Bone Metastasis
- What is being tested?
- Zoledronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteGermany
- Study dates
- May 2006to Jul 2009
- 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
- Prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment.
- Breast cancer with at least one cancer-related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential and Performance status ECOG 0-2
- Normal liver and kidney function
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone.
Who cannot join
- Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L)
- Current/active dental problems including
- infection of the teeth or jawbone
- dental or fixture trauma
- current or previous osteonecrosis of the jaw
- exposed bone in the mouth
Show all 13Show fewer
- slow healing after dental procedures
- recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
- Patients with clinically symptomatic brain metastases. Severe physical or psychological concomitant diseases expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety
- Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG
- History of diseases with influence on bone metabolism such as Paget´s disease and primary hyperparathyroidism and with need of treatment for osteoporosis (defined according to DVO, T-Score ≤2.5).
- Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month
- Additional protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-arm Multicenter Study to Evaluate Effect of Intravenous Zoledronic Acid on Bone Metabolism Given Over 4 Months in Patients With Prostate Cancer or Breast Cancer and Bone Metastasis
Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer.
The purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.
- Conditions
- Prostate Cancer, Breast Cancer, Bone Metastasis
- Being tested
- Zoledronic Acid
- Keywords
- serum bone markers, bone metastasis, prostate cancer, breast cancer, quality of life, bisphosphonates
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Also called ZOL446
every 4 weeks for 4 months
| Study group | Role | What they receive |
|---|---|---|
| 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.
Bone turnover assessed by bone turnover parameters
Measured: every 30 days
Secondary outcomes (5)
Pain
Measured: every 30 days
Change in prostate specific antigen
Measured: every 30 days
Quality of Life
Measured: every 30 days
Correlation between pain and bone turnover
Measured: at end of study
Correlation between bone complications and bone turnover
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 411 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
- NCT00334139
- Sponsor's protocol ID
- CZOL446EDE28
- Status last verified
- Feb 2017
- First submitted
- 2 Jun 2006
- Last updated
- 7 Feb 2017
- Results posted
- No
Publications
Thadepalli H, Gorbach SL, Broido PW, Norsen J, Nyhus L. Abdominal trauma, anaerobes, and antibiotics. Surg Gynecol Obstet. 1973 Aug;137(2):270-6. No abstract available.
PubMed 4723349
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Multicenter Study to Evaluate Effect of Intravenous Zoledronic Acid on Bone Metabolism Given Over 4 Months in Patients With Prostate Cancer or Breast Cancer and Bone Metastasis
- ClinicalTrials.gov ID
- NCT00334139
- Acronym / sponsor ID
- CZOL446EDE28
- Conditions
- Prostate Cancer, Breast Cancer, Bone Metastasis
- Keywords
- serum bone markers, bone metastasis, prostate cancer, breast cancer, quality of life, bisphosphonates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Jun 2006 (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.
Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer.
The purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 (5 listed)
- Prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment.
- Breast cancer with at least one cancer-related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential and Performance status ECOG 0-2
- Normal liver and kidney function
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone.
Key exclusion criteria (13 listed)
- Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L)
- Current/active dental problems including
- infection of the teeth or jawbone
- dental or fixture trauma
- current or previous osteonecrosis of the jaw
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 AcidAlso: ZOL446every 4 weeks for 4 months | Drug | zoledronic acid |
Primary outcome
Bone turnover assessed by bone turnover parameters
Time frame: every 30 days
5 secondary outcomes
Pain
Time frame: every 30 days
Change in prostate specific antigen
Time frame: every 30 days
Quality of Life
Time frame: every 30 days
Correlation between pain and bone turnover
Time frame: at end of study
Correlation between bone complications and bone turnover
Time frame: end of 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 7 Feb 2017.
- Results publication: PubMed 4723349Thadepalli H, Gorbach SL, Broido PW, Norsen J, Nyhus L. Abdominal trauma, anaerobes, and antibiotics. Surg Gynecol Obstet. 1973 Aug;137(2):270-6. No abstract available.
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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
1 site 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 Prostate Cancer and Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Germany.
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 13 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 7 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 1 site in Germany. 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?
Bone turnover assessed by bone turnover parameters (time frame: every 30 days). 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 NCT00334139, which also lists 1 linked publication.
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 7 Feb 2017.