A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00087659
First received: July 12, 2004
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: zoledronic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

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

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

Study Start Date: December 2003
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087659

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

No publications provided

ClinicalTrials.gov Identifier: NCT00087659     History of Changes
Other Study ID Numbers: CZOL446GUS63, US63, US72 H014
Study First Received: July 12, 2004
Last Updated: November 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
ADT, BMD, US63, H014

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014