Prostate CancerPhase 3NCT00171639
The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis
A Phase 3 study testing zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals at 7 sites in United States.
Trial summary
This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are… 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
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2004to Mar 2007
- 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
- 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
- Stage M0: Patients just starting ADT must be stage M0 [PSA <10 (then bone scan not needed) or negative bone scan (regardless of PSA)]. Patients already on ADT must have been M0 at the initiation of ADT and have maintained a stable, low PSA (< 2.0) on continuous ADT since that time.
- 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 from the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible. For patients already on ADT, the therapy must be continuous, and if there is more than one missed or delayed dose (> 1 mo delay) in any one year period, the patient is not eligible.
- Patient with a baseline BMD T-score <-2.0 in the lumbar spine (L2-L4) and/or 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 bisphosphonate therapy in the past 6 months
- Metabolic bone disease including Paget's disease or hyperparathyroidism or vitamin D deficiency. Patients with vitamin D deficiency or secondary hyperparathyroidism due to vitamin D deficiency may be treated and reassessed for consideration for the trial, as detailed in Appendix 9.
- Radiographic evidence of bone metastases
- Patients who have received treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy for up to one month duration, e.g. 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 21Show fewer
- 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
- Patients with clinical or radiological evidence of existing fracture in the lumbar spine or either hip
- Patients with history of lumbar spine surgery that directly involved the bone or resulted in implanted hardware; or rendered the lumbar spine not evaluable (Some patients with a history of laminectomy alone may qualify).
- Patients with history of unilateral fracture of hip due to trauma or unilateral hip surgery and the other hip and lumbar spine are not evaluable.
- Patients for whom the lumbar spine and at least one hip are not evaluable for any reason.
- Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days
- Patients with any prior treatment for osteoporosis except for calcium and vitamin D
- Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 40 ml/minute or less (Use Cockcroft-Gault equation. See Appendix 5).
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)\
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
VAWNY Buffalo
Buffalo, New York, 14215
West Side VMAC
Chicago, Illinois, 60612
Hines VA Medical Center
Hines, Illinois, 60141
Kansas City VMAC
Kansas City, Missouri, 64128
VA Medical Center-Long Beach
Long Beach, California, 90822
Southern AZ VA Health Care System
Tucson, Arizona, 85723
Washington VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT).
In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have established osteoporosis.
- Conditions
- Prostate Cancer
- Being tested
- 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.
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
Measured: 12 months
Secondary outcomes (1)
Percent change in bone mineral density of the total hip (including femoral neck, trochanteric region, and Ward's triangle) following one year of therapy.
Measured: 12 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 startJun 2004
- Primary completionMar 2007
- Study completionMar 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nirmala Bhoopalam, MD, Principal investigator, Hines VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171639
- Sponsor's protocol ID
- CZOL446EUS72
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Campbell SC, Bhoopalam N, Moritz TE, Pandya M, Iyer P, Vanveldhuizen P, Ellis NK, Thottapurathu L, Garewal H, Warren SR, Friedman N, Reda DJ. The use of zoledronic acid in men receiving androgen deprivation therapy for prostate cancer with severe osteopenia or osteoporosis. Urology. 2010 May;75(5):1138-43. doi: 10.1016/j.urology.2009.11.083. Epub 2010 Mar 19.
PubMed 20303574
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
- The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis
- ClinicalTrials.gov ID
- NCT00171639
- Acronym / sponsor ID
- CZOL446EUS72
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (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.
This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT).
In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have established osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
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
- Stage M0: Patients just starting ADT must be stage M0 [PSA <10 (then bone scan not needed) or negative bone scan (regardless of PSA)]. Patients already on ADT must have been M0 at the initiation of ADT and have maintained a stable, low PSA (< 2.0) on continuous ADT since that time.
- 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 from the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible. For patients already on ADT, the therapy must be continuous, and if there is more than one missed or delayed dose (> 1 mo delay) in any one year period, the patient is not eligible.
Key exclusion criteria (21 listed)
- Patients who received any bisphosphonate therapy in the past 6 months
- Metabolic bone disease including Paget's disease or hyperparathyroidism or vitamin D deficiency. Patients with vitamin D deficiency or secondary hyperparathyroidism due to vitamin D deficiency may be treated and reassessed for consideration for the trial, as detailed in Appendix 9.
- Radiographic evidence of bone metastases
- Patients who have received treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy for up to one month duration, e.g. 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.
Time frame: 12 months
1 secondary outcome
Percent change in bone mineral density of the total hip (including femoral neck, trochanteric region, and Ward's triangle) following one year of therapy.
Time frame: 12 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 23 Feb 2017.
- Results publication: PubMed 20303574Campbell SC, Bhoopalam N, Moritz TE, Pandya M, Iyer P, Vanveldhuizen P, Ellis NK, Thottapurathu L, Garewal H, Warren SR, Friedman N, Reda DJ. The use of zoledronic acid in men receiving androgen deprivation therapy for prostate cancer with severe osteopenia or osteoporosis. Urology. 2010 May;75(5):1138-43. doi: 10.1016/j.urology.2009.11.083. Epub 2010 Mar 19.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Nirmala Bhoopalam, MD principal investigator
Hines VA Medical Center
7 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 Prostate Cancer, run by Novartis Pharmaceuticals at 7 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 21 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 7 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.
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?
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months. (time frame: 12 months). 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 NCT00171639, 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 23 Feb 2017.