A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

NCT ID: NCT00087659

Last Updated: 2009-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-05-31

Brief 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.

In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

zoledronic acid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Novartis

Role: STUDY_CHAIR

Novartis

Locations

Tucson VA Medical Center

Tucson, Arizona, United States

VA Medical Center - Long Beach

Long Beach, California, United States

Washington VA Medical Center

Washington D.C., District of Columbia, United States

Veterans Affairs Medical Center

Augusta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

West Sde Vamc

Chicago, Illinois, United States

Hines VA Medical Center

Hines, Illinois, United States

Louisville VAMC

Louisville, Kentucky, United States

West Roxbury VAMC

West Roxbury, Massachusetts, United States

John D. Dingell VA Medical Center

Detroit, Michigan, United States

Department of Veterans Affairs

Minneapolis, Minnesota, United States

Kansas City VAMC

Kansas City, Missouri, United States

Department of Veterans Affairs

East Orange, New Jersey, United States

VAWNY, Buffalo

Buffalo, New York, United States

Portland/Vancouver

Portland, Oregon, United States

WJB Dorn Veteran Affairs Medical Center

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

US63, US72 H014

Identifier Type: -

Identifier Source: secondary_id

CZOL446GUS63

Identifier Type: -

Identifier Source: org_study_id