A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

Exclusion Criteria

• •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