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Prostate CancerPhase 4NCT00035997

Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

A Phase 4 study testing Zometa in people with Prostate Cancer, run by Novartis Pharmaceuticals at 56 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 trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. 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?
Zometa
How many people
261 participants
Where
56 sitesUnited States
Study dates
Apr 2002to Jan 2004
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

Who may be able to join

  • Signed informed consent
  • Age > 18 years
  • Histologically confirmed diagnosis of carcinoma of the prostate
  • Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
  • Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either < 6 months or > 6 months
  • ECOG performance status of 0, 1, or 2

Who cannot join

  • Patients who are hormone sensitive without metastatic disease to the bone
  • Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
  • Patients who are not treated with LHRH agonist or other hormonal treatments
  • Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
  • Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
  • Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 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)

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Advanced Urology Medical Center

    Anaheim, California, 92801

  • Alaska Clinical Research Center, LLC

    Anchorage, Alaska, 99508

  • Roger N. Andrews, MD Inc.

    Arcadia, Pennsylvania, 91007

  • Georgia Urology Research Institute

    Atlanta, Georgia, 30342

  • Urologic Surgery, PC

    Bala-Cynwyd, Pennsylvania, 19004

  • Norwood Clinic

    Birmingham, Alabama, 35234

  • Boulder Medical Center

    Boulder, Colorado

  • James W. Thompson, MD Ltd.

    Bryn Mawr, Pennsylvania, 09010

  • Research Across America

    Carrollton, Texas, 75010

  • Cary Urology, P.A.

    Cary, North Carolina, 27511

  • CAMC Clinical Trials

    Charleston, West Virginia, 25304

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Urological Associates PC

    Davenport, Iowa, 52807

  • Atlantic Urological Associates

    Daytona Beach, Florida, 32114

  • Urology Associates, P.C.

    Denver, Colorado, 80210

  • Urological Surgical Associates

    Edison, New Jersey

  • Southwest Florida Urologic Association

    Fort Myers, Florida

  • Urology Associates of Central CA

    Fresno, California, 93720

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Urological Surgeons of Long Island PC

    Garden City, New York, 11530

  • Urology Center of the South P.C.

    Germantown, Tennessee, 38138

  • Drs. Werner, Murdock and Francis PA Urology Associates

    Greenbelt, Maryland, 20770

  • Matrix Research, LLC

    Greenville, North Carolina, 29607

  • Kansas City Urology Care

    Kansas City, Missouri, 64131

  • Kingston Urological Assoc.

    Kingston, New York, 12401

  • Center for Urological Research

    La Mesa, California, 91942

  • Diagnostic Clinic

    Largo, Florida, 33770

  • DMI Health Care Group, Inc.

    Largo, Florida, 33773

  • American Academy of Urology

    Las Vegas, Nevada, 89119

  • Atlantic Urological Medical Group

    Long Beach, California, 90806

  • Advanced Urology Medical Offices

    Los Angeles, California, 90045

  • Advanced Urology Medical Office

    Los Angeles, California, 90045

  • Marvin Stein, MD

    Margate, Florida, 33063

  • Urology Associates of Middlesex County, Inc.

    Marlborough, Massachusetts, 01752

  • Miami Cancer Institute

    Miami, Florida, 33143

  • Urology Institute of Pittsburgh

    Monroeville, Pennsylvania, 15146

  • UroResearch, LLC

    Morristown, New Jersey, 07960

  • Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Murfreesboro Medical Clinic

    Murfreesboro, Tennessee, 37130

  • Grand Strand Urology

    Myrtle Beach, South Carolina, 29572

  • Urology Associates, PA

    Nashville, Tennessee, 37209

  • Advanced Research Institute

    New Port Richey, Florida, 34652

  • Florida Foundation for Healthcare Research

    Ocala, Florida, 34474

  • Urology Associates of Northeast Florida, PA

    Orange Park, Florida, 32073

  • Winter Park Urology Associates

    Orlando, Florida, 32803

  • Southwest Urology

    Parma, Ohio, 44129

  • Shaukat M. Qureshi, MD

    Pennsville, New Jersey, 08070

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Lakeside Urology, P.C.

    Saint Joseph, Michigan, 49085

  • Millennium Medical Center

    Southfield, Michigan, 48075

  • The Prostate Center of Greater St. Louis

    St Louis, Missouri, 63136

  • Pinellas Urology, Inc.

    St. Petersburg, Florida, 33710

  • Urology Associates

    Stratford, New Jersey

  • Southeastern Urological Center

    Tallahassee, Florida, 32308

  • Associates in Urology, LLC

    West Orange, New Jersey, 07052

  • Center for Urologic Care of Berks County

    West Reading, Pennsylvania, 19611

Other trials in United States

About this study

Official title: An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.

This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:

Read more
  • 18 years of age or older
  • Histologically confirmed diagnoses of prostate cancer
  • Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
  • Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments

Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.

Conditions
Prostate Cancer
Being tested
Zometa
Keywords
Hormone-sensitive Prostate Cancer, Prostate Cancer, Bone Metastasis
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ZometaDrug

What is being measured

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

  1. Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months

Secondary outcomes (4)

  1. Changes in biochemical markers of bone turnover over 12 months

  2. Changes in bone mineral density of the total hip at 12 months

  3. Time to first skeletal-related event

  4. Overall safety measured by adverse events (AEs)

Timeline

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

  1. First posted8 May 2002 (estimated)
  2. Study startApr 2002
  3. Primary completionJan 2004
  4. Study completionJan 2004

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00035997
Sponsor's protocol ID
CZOL446EUS24
Other IDs
US24
Status last verified
Nov 2009
First submitted
7 May 2002
Last updated
23 Nov 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zometa in people with Prostate Cancer, run by Novartis Pharmaceuticals at 56 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 6 inclusion and 7 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 56 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?

Changes in bone mineral density of the lumbar spine (L2-L4) at 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 NCT00035997.

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.

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