A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy
2 other identifiers
interventional
N/A
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2003
Typical duration for not_applicable prostate-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 12, 2004
CompletedFirst Posted
Study publicly available on registry
July 14, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 23, 2009
November 1, 2009
July 12, 2004
November 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
Secondary Outcomes (1)
Percent change in bone mineral density of the total hip (including femoral neck, trachanteric region, and Ward's triangle) following one year of therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Tucson VA Medical Center
Tucson, Arizona, 85723, United States
VA Medical Center - Long Beach
Long Beach, California, 90822, United States
Washington VA Medical Center
Washington D.C., District of Columbia, 20422, United States
Veterans Affairs Medical Center
Augusta, Georgia, 30904, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
West Sde Vamc
Chicago, Illinois, 60612, United States
Hines VA Medical Center
Hines, Illinois, 60141, United States
Louisville VAMC
Louisville, Kentucky, 40206, United States
West Roxbury VAMC
West Roxbury, Massachusetts, 02132, United States
John D. Dingell VA Medical Center
Detroit, Michigan, 48201, United States
Department of Veterans Affairs
Minneapolis, Minnesota, 55417, United States
Kansas City VAMC
Kansas City, Missouri, 64128, United States
Department of Veterans Affairs
East Orange, New Jersey, 07018, United States
VAWNY, Buffalo
Buffalo, New York, 14215, United States
Portland/Vancouver
Portland, Oregon, 97207, United States
WJB Dorn Veteran Affairs Medical Center
Columbia, South Carolina, 29209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2004
First Posted
July 14, 2004
Study Start
December 1, 2003
Study Completion
May 1, 2007
Last Updated
November 23, 2009
Record last verified: 2009-11