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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171639
First received: September 12, 2005
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Use of Zoledronic Acid in Men on Androgen Deprivation Therapy for Prostate Cancer With Preexisting Osteoporosis

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  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
  • 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.

  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: NCT00171639

Locations
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
Investigators
Principal Investigator: Nirmala Bhoopalam, MD Hines VA Medical Center
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171639     History of Changes
Other Study ID Numbers: CZOL446EUS72
Study First Received: September 12, 2005
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014