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

NCT00063609 | Completed Phase 4

• 2 other identifiers: CZOL446GUS45ZENITH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 44

Brief 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. 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

Keywords

Prostate Cancer; Bone Loss; Osteoporosis; Bone Mineral Density; Androgen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Percent changes in bone mineral density of the total hip

• biochemical markers of bone turnover at one year

Interventions

zoledronic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (44)

Millennium Therapeutics & Research

Birmingham, Alabama, 35205, United States

Location

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

Alaska Clinical Research Center

Anchorage, Alaska, 99508, United States

Location

Advanced Clinical Therapeutics

Tucson, Arizona, 85712, United States

Location

Donald Gleason, MD

Tucson, Arizona, 85712, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Advanced Urology Med. Center

Anaheim, California, 92801, United States

Location

Atlantic Urological Medical Group

Long Beach, California, 90806, United States

Location

San Diego Uro. Research

San Diego, California, 92101, United States

Location

Western Clinical Research

Torrance, California, 90505, United States

Location

Connecticut Surgical Group

Hartford, Connecticut, 06106, United States

Location

Grove Hill Urology

New Britain, Connecticut, 06052, United States

Location

Atlantic Urological Associates

Daytona Beach, Florida, 32114, United States

Location

University of Miami School of Medicine, Dept. of Urology

Miami, Florida, 33176, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34652, United States

Location

Urosearch

Ocala, Florida, 34470, United States

Location

Southeastern Urological Center, PA

Tallahassee, Florida, 32308, United States

Location

Medisphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

The Iowa Clinic, PC, Iowa Urology Research

Des Moines, Iowa, 50309, United States

Location

Summitt Clinical Research

Owings Mills, Maryland, 21117, United States

Location

Millennium Medical Center

Southfield, Michigan, 48075, United States

Location

Quality Clinical Research LLC

Springfield, Nebraska, 68059, United States

Location

Associated Urologic Specialist, PA

Marlton, New Jersey, 08053, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Associates In Urology, LLC

West Orange, New Jersey, 07052, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Urological Surgeons of L.I.

Garden City, New York, 11530, United States

Location

Staten Island Urological Research, PC

Staten Island, New York, 10304, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Urological Associates, Inc.

Columbus, Ohio, 43222, United States

Location

Mount Vernon Urological Associates

Mount Vernon, Ohio, 43050, United States

Location

Oregon Urology Specialists

Eugene, Oregon, 97401, United States

Location

The Urology Clinic

Portland, Oregon, 97210, United States

Location

Urologic Associates of Allentown

Allentown, Pennsylvania, 18103, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Triangle Urological Group

Pittsburgh, Pennsylvania, 15212, United States

Location

Urologic Surgeons of New England, P.C.

Providence, Rhode Island, 02904, United States

Location

University Urological Research Institute

Providence, Rhode Island, 02906, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Integrity Clinical Research, LLC

Germantown, Tennessee, 38138, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Salt Lake Research

Salt Lake City, Utah, 84124, United States

Location

Seattle Urological Associates

Seattle, Washington, 98704, United States

Location

Rockwood Clinic

Spokane, Washington, 99220, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Bone Diseases, Metabolic; Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2003
• First Posted: July 3, 2003
• Study Start: April 1, 2003
• Study Completion: April 1, 2005
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

US (44)