Status:
COMPLETED
A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00087659
Start Date
December 1 2003
End Date
May 1 2007
Last Update
November 23 2009
Active Locations (16)
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1
Tucson VA Medical Center
Tucson, Arizona, United States, 85723
2
VA Medical Center - Long Beach
Long Beach, California, United States, 90822
3
Washington VA Medical Center
Washington D.C., District of Columbia, United States, 20422
4
Veterans Affairs Medical Center
Augusta, Georgia, United States, 30904