Prostate CancerNCT00087659
A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy
A study testing zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals at 16 sites in United States.
Trial summary
This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- zoledronic acid
- How many people
- Not given
- Where
- 16 sitesUnited States
- Study dates
- Dec 2003to May 2007
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age > 18 years
- Histologically confirmed diagnosis of carcinoma of the prostate
- No distant metastases at the start of ADT and continuously low PSA (<2.0) on continuous ADT (stage Tany Nany MO).
- Patients initiating or receiving ADT with a LHRH agonist (with or without an antiandrogen) and with the intended duration of ADT of at least 12 months at the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible.
- Patient with a baseline BMD T-score at or above -2.0 standard deviations in the lumbar spine (L2-L4) and the total hip are eligible
- Life expectancy of at least 12 months
- Zubrod performance status of 0, 1, or 2
Who cannot join
- Patients who received any prior bisphosphonate therapy in the past 6 months
- Metabolic bone disease including Paget's disease or hyperparathyroidism
- Radiographic evidence of bone metastases
- Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
- Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
- Current treatment with estrogen or complementary medicines known to contain estrogens
Show all 20Show fewer
- Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip
- Patients with a history of fracture with low-intensity or no associated trauma
- Patients with any prior treatment for osteoporosis
- Patients with previous or concomitant malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, and colonic polyps with non-invasive malignancy which have been removed
- Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including:
- uncontrolled infections
- uncontrolled type 2 diabetes mellitus
- diseases with influence on bone metabolism, such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction
- cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up
- History of surgery at the lumbosacral spine, with or without implantable devices, bilateral hip replacement or bilateral hip surgery with implantation of an appliance
- Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days
- Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Veterans Affairs Medical Center
Augusta, Georgia, 30904
VAWNY, Buffalo
Buffalo, New York, 14215
West Sde Vamc
Chicago, Illinois, 60612
WJB Dorn Veteran Affairs Medical Center
Columbia, South Carolina, 29209
Atlanta VA Medical Center
Decatur, Georgia, 30033
John D. Dingell VA Medical Center
Detroit, Michigan, 48201
Department of Veterans Affairs
East Orange, New Jersey, 07018
Hines VA Medical Center
Hines, Illinois, 60141
Kansas City VAMC
Kansas City, Missouri, 64128
VA Medical Center - Long Beach
Long Beach, California, 90822
Louisville VAMC
Louisville, Kentucky, 40206
Department of Veterans Affairs
Minneapolis, Minnesota, 55417
Portland/Vancouver
Portland, Oregon, 97207
Tucson VA Medical Center
Tucson, Arizona, 85723
Washington VA Medical Center
Washington D.C., District of Columbia, 20422
West Roxbury VAMC
West Roxbury, Massachusetts, 02132
About this study
This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year.
In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.
- Conditions
- Prostate Cancer
- Being tested
- zoledronic acid
- Keywords
- ADT, BMD, US63, H014
- 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.
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
Secondary outcomes (1)
Percent change in bone mineral density of the total hip (including femoral neck, trachanteric region, and Ward's triangle) following one year of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2004 (estimated)
- Study startDec 2003
- Study completionMay 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087659
- Sponsor's protocol ID
- CZOL446GUS63
- Other IDs
- US63, US72 H014
- Status last verified
- Nov 2009
- First submitted
- 12 Jul 2004
- Last updated
- 23 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT00087659
- Acronym / sponsor ID
- CZOL446GUS63
- Conditions
- Prostate Cancer
- Keywords
- ADT, BMD, US63, H014
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- May 2007 (actual)
- First posted
- 14 Jul 2004 (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.
This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year.
In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Age > 18 years
- Histologically confirmed diagnosis of carcinoma of the prostate
- No distant metastases at the start of ADT and continuously low PSA (<2.0) on continuous ADT (stage Tany Nany MO).
- Patients initiating or receiving ADT with a LHRH agonist (with or without an antiandrogen) and with the intended duration of ADT of at least 12 months at the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible.
Key exclusion criteria (20 listed)
- Patients who received any prior bisphosphonate therapy in the past 6 months
- Metabolic bone disease including Paget's disease or hyperparathyroidism
- Radiographic evidence of bone metastases
- Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
- Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
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
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
1 secondary outcome
Percent change in bone mineral density of the total hip (including femoral neck, trachanteric region, and Ward's triangle) following one year of therapy.
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 Nov 2009.
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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 study chair
Novartis
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals at 16 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 8 inclusion and 20 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 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
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?
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 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 23 Nov 2009; AzTrials last refreshed its copy on 6 Nov 2026.