A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

November 20, 2009 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Tucson VA Medical Center
    • California
      • Long Beach, California, United States, 90822
        • VA Medical Center - Long Beach
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington VA Medical Center
    • Georgia
      • Augusta, Georgia, United States, 30904
        • Veterans Affairs Medical Center
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • West Sde Vamc
      • Hines, Illinois, United States, 60141
        • Hines VA Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Louisville VAMC
    • Massachusetts
      • West Roxbury, Massachusetts, United States, 02132
        • West Roxbury VAMC
    • Michigan
      • Detroit, Michigan, United States, 48201
        • John D. Dingell VA Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Department of Veterans Affairs
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VAMC
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Department of Veterans Affairs
    • New York
      • Buffalo, New York, United States, 14215
        • VAWNY, Buffalo
    • Oregon
      • Portland, Oregon, United States, 97207
        • Portland/Vancouver
    • South Carolina
      • Columbia, South Carolina, United States, 29209
        • WJB Dorn Veteran Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.

Secondary Outcome Measures

Outcome Measure
Percent change in bone mineral density of the total hip (including femoral neck, trachanteric region, and Ward's triangle) following one year of therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 12, 2004

First Submitted That Met QC Criteria

July 13, 2004

First Posted (Estimate)

July 14, 2004

Study Record Updates

Last Update Posted (Estimate)

November 23, 2009

Last Update Submitted That Met QC Criteria

November 20, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446GUS63
  • US63, US72 H014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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