The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171639
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 23, 2017
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Brief Summary:

This study is being conducted to evaluate the effect of an investigational drug on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT).

In order to participate, male patients 18 years and older must be veterans from participating Veterans Administration Medical Centers that are receiving ADT for prostate cancer and have established osteoporosis.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: zoledronic acid Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis
Study Start Date : June 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

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

Secondary Outcome Measures :
  1. Percent change in bone mineral density of the total hip (including femoral neck, trochanteric region, and Ward's triangle) following one year of therapy. [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • Age > 18 years
  • Histologically confirmed diagnosis of carcinoma of the prostate
  • Stage M0: Patients just starting ADT must be stage M0 [PSA <10 (then bone scan not needed) or negative bone scan (regardless of PSA)]. Patients already on ADT must have been M0 at the initiation of ADT and have maintained a stable, low PSA (< 2.0) on continuous ADT since that time.
  • 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 from the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible. For patients already on ADT, the therapy must be continuous, and if there is more than one missed or delayed dose (> 1 mo delay) in any one year period, the patient is not eligible.
  • Patient with a baseline BMD T-score <-2.0 in the lumbar spine (L2-L4) and/or 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 bisphosphonate therapy in the past 6 months
  • Metabolic bone disease including Paget's disease or hyperparathyroidism or vitamin D deficiency. Patients with vitamin D deficiency or secondary hyperparathyroidism due to vitamin D deficiency may be treated and reassessed for consideration for the trial, as detailed in Appendix 9.
  • Radiographic evidence of bone metastases
  • Patients who have received treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy for up to one month duration, e.g. 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 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
  • Patients with clinical or radiological evidence of existing fracture in the lumbar spine or either hip
  • Patients with history of lumbar spine surgery that directly involved the bone or resulted in implanted hardware; or rendered the lumbar spine not evaluable (Some patients with a history of laminectomy alone may qualify).
  • Patients with history of unilateral fracture of hip due to trauma or unilateral hip surgery and the other hip and lumbar spine are not evaluable.
  • Patients for whom the lumbar spine and at least one hip are not evaluable for any reason.
  • Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days
  • Patients with any prior treatment for osteoporosis except for calcium and vitamin D
  • Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 40 ml/minute or less (Use Cockcroft-Gault equation. See Appendix 5).
  • Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)\

Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171639

United States, Arizona
Southern AZ VA Health Care System
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, Illinois
West Side VMAC
Chicago, Illinois, United States, 60612
Hines VA Medical Center
Hines, Illinois, United States, 60141
United States, Missouri
Kansas City VMAC
Kansas City, Missouri, United States, 64128
United States, New York
VAWNY Buffalo
Buffalo, New York, United States, 14215
Sponsors and Collaborators
Novartis Pharmaceuticals
Principal Investigator: Nirmala Bhoopalam, MD Hines VA Medical Center

Publications of Results:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00171639     History of Changes
Other Study ID Numbers: CZOL446EUS72
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents