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Prostate CancerPhase 4NCT00063609

The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

A Phase 4 study testing zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. 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
200 participants
Where
44 sitesUnited States
Study dates
Apr 2003to Apr 2005
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult
  • Histologically confirmed diagnosis of carcinoma of the prostate
  • No distant metastases (stage TNMO) (ie. prostate cancer without metastases)
  • Patients within one year at the day of randomization from initiation of androgen deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1
  • Patients who received any prior bisphosphonate therapy in the past 12 months will be excluded
  • Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment for osteoporosis) will be excluded
  • Patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
  • Other eligibility criteria may apply

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Urologic Associates of Allentown

    Allentown, Pennsylvania, 18103

  • Advanced Urology Med. Center

    Anaheim, California, 92801

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99508

  • Millennium Therapeutics & Research

    Birmingham, Alabama, 35205

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Urological Associates, Inc.

    Columbus, Ohio, 43222

  • Atlantic Urological Associates

    Daytona Beach, Florida, 32114

  • The Iowa Clinic, PC, Iowa Urology Research

    Des Moines, Iowa, 50309

  • Oregon Urology Specialists

    Eugene, Oregon, 97401

  • Medisphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Urological Surgeons of L.I.

    Garden City, New York, 11530

  • Integrity Clinical Research, LLC

    Germantown, Tennessee, 38138

  • Connecticut Surgical Group

    Hartford, Connecticut, 06106

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Atlantic Urological Medical Group

    Long Beach, California, 90806

  • Associated Urologic Specialist, PA

    Marlton, New Jersey, 08053

  • University of Miami School of Medicine, Dept. of Urology

    Miami, Florida, 33176

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Mount Vernon Urological Associates

    Mount Vernon, Ohio, 43050

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Grove Hill Urology

    New Britain, Connecticut, 06052

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34652

  • Urosearch

    Ocala, Florida, 34470

  • Summitt Clinical Research

    Owings Mills, Maryland, 21117

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Triangle Urological Group

    Pittsburgh, Pennsylvania, 15212

  • The Urology Clinic

    Portland, Oregon, 97210

  • Urologic Surgeons of New England, P.C.

    Providence, Rhode Island, 02904

  • University Urological Research Institute

    Providence, Rhode Island, 02906

  • Salt Lake Research

    Salt Lake City, Utah, 84124

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • San Diego Uro. Research

    San Diego, California, 92101

  • Seattle Urological Associates

    Seattle, Washington, 98704

  • Millennium Medical Center

    Southfield, Michigan, 48075

  • Rockwood Clinic

    Spokane, Washington, 99220

  • Quality Clinical Research LLC

    Springfield, Nebraska, 68059

  • Staten Island Urological Research, PC

    Staten Island, New York, 10304

  • Southeastern Urological Center, PA

    Tallahassee, Florida, 32308

  • Western Clinical Research

    Torrance, California, 90505

  • Advanced Clinical Therapeutics

    Tucson, Arizona, 85712

  • Donald Gleason, MD

    Tucson, Arizona, 85712

  • Associates In Urology, LLC

    West Orange, New Jersey, 07052

Other trials in United States

About this study

Official title: The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy

The purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. In order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. In addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate.

Patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. Also patients who are receiving treatment for osteoporosis are not eligible to participate.

Inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.

Conditions
Prostate Cancer
Being tested
zoledronic acid
Keywords
Prostate Cancer, Bone Loss, Osteoporosis, Bone Mineral Density, Androgen Deprivation Therapy
Medical subject headings
Prostatic Neoplasms, Bone Diseases, Metabolic, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.

Secondary outcomes (2)

  1. Percent changes in bone mineral density of the total hip

  2. biochemical markers of bone turnover at one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2003 (estimated)
  2. Study startApr 2003
  3. Study completionApr 2005

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00063609
Sponsor's protocol ID
CZOL446GUS45
Other IDs
ZENITH
Status last verified
Sep 2017
First submitted
1 Jul 2003
Last updated
13 Sep 2017
Results posted
No

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 at 44 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?

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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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 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?

Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.. 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 NCT00063609.

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 13 Sep 2017.

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