A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy
NCT ID: NCT00087659
Last Updated: 2009-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2003-12-31
2007-05-31
Brief Summary
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In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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zoledronic acid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Principal Investigators
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Novartis
Role: STUDY_CHAIR
Novartis
Locations
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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
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Other Identifiers
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US63, US72 H014
Identifier Type: -
Identifier Source: secondary_id
CZOL446GUS63
Identifier Type: -
Identifier Source: org_study_id